supplier quality engineer

Kestra Medical Technologies, Inc.

<div><p>The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets.
</p><p>The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable
</p><p>technologies with proven device therapies. Kestra&rsquo;s solutions combine high quality and technical performance
</p><p>with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new
</p><p>ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect
</p><p>life.</p><p></p><p>
The Supplier Quality Engineer is responsible for ensuring the delivery of high-quality, life-saving products by
</p><p>managing supplier quality throughout the product lifecycle&mdash;from development through production. This role
</p><p>collaborates cross-functionally with R&amp;D, Supply Chain, and external suppliers to assess and monitor supplier
</p><p>quality systems, drive process improvements, and ensure compliance with regulatory and internal standards. Key
</p><p>responsibilities include supplier approval coordination, developing and maintaining weekly and monthly quality
</p><p>metrics&mdash;including Supplier Approvals, Scorecards, SCARs, and Process Quality&mdash;to support data-driven decision-making and continuous improvement. Additionally, the role supports supplier audits and corrective action
</p><p>initiatives across the supply base.</p><p>
ESSENTIAL DUTIES</p><ul><li>Develops and maintains run charts, pareto charts and action trackers for Supplier in-process quality data.
</li><li>Maintains supplier quality metrics and charts for supplier approvals and supplier SCARS.</li><li>Processes supplier approval requests and requests required data to support supplier approval.</li><li>Collects data and creates quarterly, and annual supplier scorecards.</li><li>Audits Supplier source inspection records and lot acceptance records.</li><li>Develops audit plans, conducts audits, writes audit reports, and manages corrective actions as required for
</li></ul><p>low-medium risk suppliers with direction from Sr Supplier Quality Engineers.</p><ul><li>Identifies and drives supplier continuous improvement through action plans and process qualification reviews
</li></ul><p>and approvals.</p><ul><li>Maintain supplier key performance indicators (KPIs) to support supplier score cards, and drive improvements.</li><li>Drive supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier
</li></ul><p>corrective action requests (SCAR).</p><ul><li>Maintain 100% compliance with Kestra Medical processes and procedures.</li></ul><p>
COMPETENCIES
</p><ul><li>Passion: Contagious excitement about the company &ndash; sense of urgency. Commitment to continuous
</li></ul><p>improvement.</p><ul><li>Integrity: Commitment, accountability, and dedication to the highest ethical standards.</li><li>Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or
</li></ul><p>service.</p><ul><li>Action/Results: High energy, decisive planning, timely execution.</li><li>Innovation: Generation of new ideas from original thinking.</li></ul><p>
Kestra Medical Technologies, Inc. Reviewed 11.2025 Supplier Quality Engineer</p><ul><li>Customer Focus: Exceed customer expectations, quality of products, services, and experience always present
</li></ul><p>of mind.
</p><ul><li>Emotional Intelligence: Recognizes, understands, manages one&rsquo;s own emotions and is able to influence
</li></ul><p>others. A critical skill for pressure situations.
</p><p><b>Requirements</b></p><p><b>
QUALIFICATIONS
</b></p><p>Education/Experience Required:
</p><ul><li>Bachelor's degree in engineering or technical science, or equivalent combination of education and directly
</li></ul><p>relevant experience.</p><ul><li>3+ years&rsquo; directly relevant experience, with prior experience in an FDA/cGMP or regulated environment.</li><li>Working knowledge of PPAP and IQ/OQ/PQ validation techniques.</li><li>Strong written and verbal communication skills.</li><li>Direct experience as a Manufacturing Engineer, Test Engineer, Quality Engineer, or Supplier Quality Engineer.</li></ul><p>
</p><p>Preferred:
</p><ul><li>Certified quality auditor.</li><li>Experienced with six-sigma and lean manufacturing techniques.</li><li>Direct experience working with class 3 medical devices.</li></ul><p>
SUPERVISORY RESPONSIBILITIES:
</p><ul><li>None</li></ul><p>
WORK ENVIRONMENT</p><ul><li>Indoor open office environment</li><li>Minimal noise volume typical to an office environment</li><li>Extended hours when needed</li><li>Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug
</li></ul><p>Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a
</p><p>condition of employment.</p><p>
PHYSICAL DEMANDS</p><ul><li>Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse
</li></ul><p>usage</p><ul><li>Frequent stationary position, often standing or sitting for prolonged periods of time</li><li>Frequent computer use</li><li>Frequent phone and other business machine use</li><li>Occasional lifting required, up to 20 pounds</li></ul><p>
TRAVEL</p><ul><li>Frequent travel is required, 10-20%</li></ul><p><b>
Benefits</b></p><p>
Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.</p><p>
Pay equity is an important part of Kestra&rsquo;s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.</p><p></p><p>
Salary: Annualized at $100,000 - $120,000, plus bonus. Depending on experience.</p><p><br>
Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, age, sexual orientation, gender identity and/or expression, marital status, disability, physical or mental status or any other characteristic protected by law.</p><p>
We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.</p><p>
Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.</p></div>

Supplier Quality Engineer

Uniforce Facilities

<p><b>Job Title:</b> Supplier Quality Engineer</p><p><b>Key Responsibilities:</b></p><ul><li>Evaluate and qualify new suppliers.</li><li>Conduct supplier audits and performance reviews.</li><li>Investigate and resolve supplier quality issues.</li><li>Work with suppliers on corrective and preventive actions.</li><li>Support continuous improvement in the supply chain.</li></ul><p><b>Requirements:</b></p><ul><li>Degree in Engineering or related field.</li><li>2+ years of experience in supplier or quality engineering.</li><li>Strong analytical and problem-solving skills.</li><li>Knowledge of quality tools and standards</li><li><b>Bike Required</b></li></ul><p><b>Contact No : 7775000296</b></p><p>Job Type: Full-time</p><p>Pay: &#8377;16,000.00 - &#8377;20,000.00 per month</p><p>Benefits:</p><ul><li>Health insurance</li><li>Provident Fund</li></ul><p>Work Location: In person</p>

Kaman Corporation

At Kaman, we are always looking for a better way. Whether we are helping keep our troops safe or pioneering safer ways to fly the globe, we approach every challenge with an innovation mindset. We consider our people to be the key to our success and are looking for candidates who share our core values of Respect, Excellence, Accountability, Creativity and Honor (REACH). Find out more about us at Kaman.com/Careers.
<br><br>
WE are currently seeking a talented Supplier Quality Engineer at our Middletown, CT facility. This role is fully onsite.
<br><br>
The SQE ensures suppliers meet contractual/regulatory and internal quality standards for parts and materials. They will need to have exp performing audits, analyze supplier processes and products, conduct root cause analysis for issues with parts, drive corrective actions, and reject/do a part stoppage if they arrive with defects. They must be able to do supplier qualification, performance monitoring, development, and document first article inspections. They qualify and evaluate new suppliers and monitor performance, conduct audit of supplier facilities and processes to ensure compliance with ISO/AS9100 quality standards and contractual requirements. Investigate and analyze supplier defects. See description for more specific details.
<br><br>
The SQE works under the general direction of the Manager, Program and Supplier Quality Assurance with minimum supervision performing supplier source inspections, first article inspections, supplier surveys and audits assuring supplier corrective action where required. Interface with procurement and other personnel within the procurement organization.
<br><br>
Specific duties and responsibilities include, but are not limited to the following:
<br><br>
<ul>
<li>Maintain the supplier rating system, which will define the total cost of ownership of products procured from suppliers.</li>
<li>Implement and maintain a supplier approval system that will, in a cost-effective manner, qualify suppliers to do business with the company and meet varied purchase order requirements.</li>
<li>Evaluates lean initiatives at supplier facilities and assists in implementing lean as necessary.</li>
<li>Assures the means for procurement to issue purchase orders to qualified/approved suppliers and all requirements are included in the purchase orders.</li>
<li>Manage the supplier corrective action system to identify and correct supplier problems in a timely manner.</li>
<li>Coordinate Supplier Manufacturing Readiness Reviews and manage Supplier Request for Variance (when applicable).</li>
<li>The Supplier Quality Engineer will conduct capability assessments that verify supplier qualifications, travel to assigned suppliers, and lead multiple projects to completion.</li>
<li>Act as primary interface between the company and suppliers in resolving technical problems and performing source control inspections.</li>
<li>Coordinate with functional departments and ensure that problems are resolved in a timely manner.</li>
<li>Aid in determining the responsibility of discrepant hardware already received into the company and issued to the shop or shipped to customers.</li>
<li>Establish and maintain effective communications with other operating departments and suppliers to facilitate problem identification/resolution and compliance with various specification requirements for supplier control.</li>
<li>Prepare and maintain reports such as supplier performance, survey results, specification compliance, corrective actions, etc.</li>
<li>Your responsibilities will include conducting audit, analyzing defect trends.</li>
<li>Monitoring supplier performance and response times to ensure production continuity.</li>
<li>Managing supplier corrective action reports.</li>
<li>Developing and implementing supplier quality-related training programs for the quality and sourcing teams.</li>
<li>Interface with cell managers to assure all applicable inspections/tests are performed and to assure that only acceptable hardware is received into the company.</li>
<li>Collect and analyze supplier quality and delivery data.</li>
<li>Develop and implement cost effective intervention plans to improve quality and on-time-delivery ratings.</li>
<li>Maintain a list of approved suppliers.</li>
<li>Monitor suppliers for continuous improvements.</li>
<li>Ability to travel for supplier visits.</li>
</ul>
<b>Requirements:</b><br>
<ul>
<li>Broad knowledge of a general technical field such as electrical, mechanical, industrial engineering.</li>
<li>BS degree in related engineering field.</li>
<li>Thorough understanding of ISO 9000 regulations certification process.</li>
<li>Fully Onsite</li>
<li>5+ years’ work experience in Supplier Quality and Aerospace.</li>
<li>Detailed-oriented, good communications skills, critical thinking, methodical, and organized.</li>
</ul>
Kaman is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or other protected characteristics protected by law. Kaman and all its related companies fully endorse equal opportunity for all.
<br>Kaman endeavors to make the careers website accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the Corporate Human Resources department at 860-243-7384. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
<br><b>Notice Requirement:</b> It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ariat International

<div>
 <p>
  <strong>
   Summary:
  </strong>
 </p>
 <p>
  Ariat International is seeking a Supplier Quality Engineer to support apparel quality manufacturing. This role will be based in Egypt (Cairo) and will play a crucial role in ensuring that the apparel products produced by our suppliers meet the highest quality standards. This role will work closely with garment suppliers at various stages of the product lifecycle to ensure robust quality management systems are in place, assist with challenges during product development, confirm successful product qualifications, conduct product inspections, lead root cause analysis and CAPA.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities:
  </strong>
 </p>
 <ul>
  <li>
   Collaborate with Supplier Quality Team to execute Supplier Quality Strategy with a goal of onboarding strong suppliers, driving process improvement, managing risks, and ensuring quality production
   <em>
    (Factory Audits, Supplier Pre-Production Meetings, Sample Evaluations, Inspections, etc.).
   </em>
  </li>
  <li>
   Review supplier performance and scorecards with suppliers to drive improvements.
  </li>
  <li>
   Lead supplier qualification plans/activities, issue resolution, supplier corrective actions.
  </li>
  <li>
   Advise on supplier selection through qualification and audit process.
  </li>
  <li>
   Develop positive relationships and work closely with HQ teams - Sourcing, Production, Tech Design and Quality.
  </li>
  <li>
   Provide quality engineering expertise.
  </li>
  <li>
   Execute supplier quality and performance strategy and system.
  </li>
  <li>
   Identify product quality risk and develop solution plans.
  </li>
  <li>
   Arrange and conduct in-line and final product inspections and provide advice and solutions on technical issues.
  </li>
  <li>
   Conduct supplier Quality Management System audits at new and current suppliers.
  </li>
  <li>
   Participate in and advise during supplier pre-production meetings to ensure Ariat Quality standards are understood and appropriate control plans are developed to meet standards.
  </li>
  <li>
   Provide QA advice on complex product items to factories before and during the manufacturing process.
  </li>
  <li>
   Check development and pre-production samples against specifications to ensure they meet standards.
  </li>
  <li>
   Provide technical advice and solutions on various product quality issues.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Requirements/Experience:
  </strong>
 </p>
 <ul>
  <li>
   At least 10 years of quality operations experience in the apparel industry
  </li>
  <li>
   Degree in Engineering, Apparel, Textiles, or other relevant discipline
  </li>
  <li>
   Quality Certifications are a plus (ex. six sigma, ASQ, etc.)
  </li>
  <li>
   Familiar with US product safety standards and regulations
  </li>
  <li>
   Strong written and verbal communication (English)
  </li>
  <li>
   Use computers and computer systems (hardware and software) in English to manage quality control information, including compiling, categorizing, calculating, auditing and verifying detailed information or data.
  </li>
  <li>
   Develop schedules and work plans to prioritize, organize, and accomplish inspection/audit/production meeting goals.
  </li>
  <li>
   Maintain professional work standards when representing Ariat to outside resources.
  </li>
  <li>
   Ability to collaborate with suppliers to remediate quality problems and settle disputes and conflicts in a positive way.
  </li>
  <li>
   Able to travel frequently, with about 70% of the time on business travel.
  </li>
 </ul>
 <p>
 </p>
</div>


Aisin Electronics Illinois, LLC.

<div><h2 class="jobSectionHeader"><b>AISIN ELECTRONICS ILLINOIS, LLC</b></h2>
<p><b>
Job Title:</b> Supplier Quality Engineer<br>
<b>Division:</b> Quality Control Department<br>
<b>Reports To:</b> Quality Control Assistant Section / Section Manager</p>
<h3 class="jobSectionHeader"><b>Summary</b></h3>
<p>
The Supplier Quality Engineer supports the Quality Engineering group by ensuring that all suppliers meet AISIN's product quality and performance requirements. This role focuses on supplier process compliance, product validation, and continuous improvement to strengthen overall supply chain quality.</p>
<h3 class="jobSectionHeader"><b>Essential Duties and Responsibilities</b></h3>
<ul>
<li><p>Support manufacturing groups through supplier improvement activities.</p>
</li>
<li><p>Manage new product initial control in compliance with AIAG and customer requirements, including process inspection setup and product verification against drawings and applicable standards.</p>
</li>
<li><p>Develop and manage supplier quality metrics (internal and external).</p>
</li>
<li><p>Oversee packing requirements and approvals for incoming goods.</p>
</li>
<li><p>Communicate supplier quality performance and feedback at appropriate intervals.</p>
</li>
<li><p>Coordinate with internal teams on requirements related to new launches, PCRs, and other relevant activities.</p>
</li>
<li><p>Create and maintain documentation and records of quality results.</p>
</li>
<li><p>Develop quality plans and manage suppliers throughout the PPAP process.</p>
</li>
<li><p>Manage supplier RMA (Return Material Authorization) activities.</p>
</li>
<li><p>Plan, implement, review, and approve supplier engineering change instructions (ECIs).</p>
</li>
<li><p>Create standard work procedures and instructions as needed.</p>
</li>
<li><p>Support cross-functional PFMEA (Process Failure Mode and Effects Analysis) activities.</p>
</li>
<li><p>Ensure incoming components meet qualification and specification standards, including oversight of receiving inspection.</p>
</li>
<li><p>Collaborate with cross-functional teams to resolve in-process and subcomponent quality issues.</p>
</li>
<li><p>Prepare materials for management review meetings (weekly, monthly, etc.).</p>
</li>
<li><p>Lead supplier corrective action implementation and evaluate results.</p>
</li>
<li><p>Conduct defect analysis and reporting.</p>
</li>
<li><p>Support supplier process audits through the Purchasing department to assess risk and drive improvement.</p>
</li>
<li><p>Assist with customer return or production line investigations alongside other quality groups.</p>
</li>
<li><p>Help maintain compliance with IATF 16949 and ISO 14001 standards.</p>
</li>
<li><p>Perform all duties in accordance with company safety and security standards.</p>
</li>
<li><p>Perform additional related tasks as assigned by management.</p>
</li>
</ul><h3 class="jobSectionHeader"><b>Supervisory Responsibilities</b></h3>
<ul>
<li><p>This position does not have direct supervisory responsibilities.</p>
</li>
</ul><h3 class="jobSectionHeader"><b>Knowledge, Skills, and Abilities</b></h3>
<ul>
<li><p>Strong understanding and application of AIAG Core Tools to relevant processes.</p>
</li>
<li><p>Proficiency in measurement using various electronic and dimensional gauges; ability to apply statistical control.</p>
</li>
<li><p>Excellent written and verbal communication skills.</p>
</li>
<li><p>Strong time management and organizational abilities.</p>
</li>
<li><p>Collaborative and cooperative approach to teamwork.</p>
</li>
<li><p>Ability to travel on short notice, including international travel as required.</p>
</li>
<li><p>Ability to work weekends and holidays as needed.</p>
</li>
<li><p>Comfortable interacting and collaborating across all levels of the organization.</p>
</li>
<li><p>Ability to understand, follow, and apply company policies, procedures, and work rules.</p>
</li>
</ul><h3 class="jobSectionHeader"><b>Qualifications, Education &amp; Experience</b></h3>
<ul>
<li><p>Bachelor of Science degree (B.Sc. or B.Eng.) in Engineering or Engineering Technology from an ABET-accredited institution required.</p>
</li>
<li><p>Accepted degrees include Electrical, Mechanical, Industrial, Control, Computer, Electro-Mechanical, Manufacturing, Aerospace, Automotive, Mechatronics, Robotics, and Systems Engineering.</p>
</li>
<li><p>1&ndash;5 years of experience in Quality Engineering preferred.</p>
</li>
<li><p>Valid passport or ability to obtain one required.</p>
</li>
</ul><h3 class="jobSectionHeader"><b>Work Environment</b></h3>
<ul>
<li><p>Exposure to dust, noise, oils, greases, grinding debris, compressed air, metal shavings, propane, solvents, and occasional heavy lifting.</p>
</li>
<li><p>Potential exposure to hazardous machinery and conditions; adherence to all safety procedures is required.</p>
</li>
<li><p>Work performed in typical manufacturing areas requiring use of PPE such as steel-toe shoes, safety glasses, and protective clothing.</p>
</li>
<li><p>Customer and supplier site visits may require additional protective equipment (e.g., cleanroom suits, sleeves, non-metallic belts).</p>
</li>
<li><p>Open office environment with frequent interaction across departments; must be able to adapt quickly to changing priorities.</p>
</li>
</ul><h3 class="jobSectionHeader"><b>Physical Demands / Requirements</b></h3>
<p>
Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.</p>
<div>
<div><div><div><div><div><b>Activity</b></div> <div><b>0&ndash;33%</b></div> <div><b>34&ndash;66%</b></div> <div><b>67&ndash;100%</b></div>
</div><br>
</div><div><div><div>Standing</div> <div></div><div>X</div>
</div><br>
<div></div><div><div>Walking</div> <div>X</div>
</div><br>
<div></div><div><div>Sitting</div> <div></div><div>X</div>
</div><br>
<div></div><div><div>Lifting (up to 40 lbs)</div> <div>X</div>
</div><br>
<div></div><div><div>Carrying (up to 40 lbs)</div> <div>X</div>
</div><br>
<div></div><div><div>Pushing/Pulling (up to 40 lbs)</div> <div>X</div>
</div><br>
<div></div><div><div>Climbing</div> <div>X</div>
</div><br>
<div></div><div><div>Balancing</div> <div>X</div>
</div><br>
<div></div><div><div>Bending/Stooping</div> <div>X</div>
</div><br>
<div></div><div><div>Crawling</div> <div>X</div>
</div><br>
<div></div><div><div>Reaching</div> <div>X</div>
</div><br>
<div></div><div><div>Reaching/Working Above Shoulder</div> <div>X</div>
</div><br>
<div></div><div><div>Walking on Uneven Ground</div> <div>X</div>
</div><br>
<div></div><div><div>Fine Manipulation</div> <div>X</div>
</div><br>
<div></div><div><div>Gross Manipulation</div> <div>X</div>
</div><br>
<div></div><div><div>Simple Grasping</div> <div>X</div>
</div><br>
<div></div><div><div>Power Grip</div> <div>X</div>
</div><br>
<div></div><div><div>Hand Twisting</div> <div>X</div>
</div><br>
<div></div><div><div>Twisting of Body</div> <div>X</div>
</div><br>
<div></div><div><div>Kneeling</div> <div>X</div>
</div><br>
<div></div><div><div>Crouching</div> <div>X</div>
</div><br>
</div></div></div></div><div></div><h3 class="jobSectionHeader"><b>Salary Range</b></h3>
<p><b>
$76,250 &ndash; $97,000</b></p>
<h3 class="jobSectionHeader"><b>Additional Information</b></h3>
<p>
This job description is not intended to create an employment agreement or contract. Duties and responsibilities may change as business needs evolve.</p>
<p>
</p>Requirements:
<p>The above intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.</p></div>

Innio

<div><div><div><div><div><div><b>The INNIO Advantage:</b></div><div>
By combining a rich legacy in the power and gas compression space with pioneering technology, <b>INNIO</b> brings our customers affordable, reliable and sustainable energy solutions for today and tomorrow.</div><div><b>
</b></div><div>
We are helping to meet today&rsquo;s energy needs with 64 GW of installed capacity and more than 50,000 of our powerful Jenbacher and Waukesha engines, which can be found in more than 100 countries. And, by harnessing our history of energy industry firsts along with the power of digital innovation, we will continue to deliver for the future.</div><p></p><div><b>
Please note that the work location for this role is our NAM HQ in Houston</b></div><p></p><div><b>
Role Description :</b></div><div><b>
</b></div><div>
The <b>Supplier Quality Engineer</b> is responsible for high product quality, customer value beyond expectations, regulatory compliance, and optimized cost of quality. This role is the technical focal point for supplier activities aimed at improving process control and quality assurance of purchased parts/components to strengthen the collaboration between INNIO and its suppliers.</div><div><b>
</b></div><div><b>
Essential Responsibilities :</b></div><div><b>
</b></div><div>
In this position, you will be responsible for</div><ul><li>Managing supply base focused on engineered systems</li><li>Act as primary interface between suppliers and INNIO internal functions on technical issues and collaborate with Sourcing, Manufacturing, Engineering and Planning</li><li>Conduct supplier audits and ensure that suppliers comply with quality procedures, standards and technical regulations</li><li>Lead qualification projects for new parts and new suppliers with focus on defect prevention.</li><li>Lead efforts to reduce product defects and cost of quality, perform root cause analyses when necessary and dispose supplier deviation requests and non-conformities</li><li>Lead supplier development activities: drive continuous improvement initiatives with suppliers and provide quality input for supplier scorecards</li></ul><div><b>
</b></div><div><b>
Qualification Requirements :</b></div><div><b>
</b></div><ul><li>Technical Degree, preferably in engineering, from an accredited university or college or equivalent</li><li>minimum of 5 years job-related experience in the (supplier) quality field in an industrial manufacturing environment.</li><li>Strong communication, problem-solving and project management skills within cross-functional and cross-regional teams</li><li>Independent, proactive, fast response, flexible work style</li><li>Ability and willingness to travel up to 40% of the time primarily in the United States</li></ul></div></div></div></div></div><p></p>

Biomerics

<div>Description:
<p><b>
Company Overview</b></p><p>
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.</p><p>
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.</p><p>
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.</p><p><b>
Job Description</b></p><p>
A Supplier Quality Engineer is responsible for ensuring the quality of products received from external suppliers by conducting thorough audits, identifying and resolving quality issues, working closely with procurement and engineering teams to implement corrective actions, and maintaining strong relationships with suppliers to continuously improve product quality and compliance with company standards You will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. You may support new product development (NPD) as needed. As the Supplier Quality Engineer, you will lead Quality Assurance (QA) in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169.</p><p><b>
Job Responsibilities</b></p><ul><li>
Supplier evaluation and selection: Assessing potential suppliers through audits and reviews to ensure they meet quality requirements and capabilities.</li><li>
Quality system oversight: Monitoring supplier quality management systems to verify compliance with company standards and industry regulations.</li><li>
Supplier audits: Conducting on-site audits at supplier facilities to evaluate manufacturing processes, quality control procedures, and documentation.</li><li>
Quality issue identification and resolution: Analyzing incoming materials and products to detect defects, performing root cause analysis, and working with suppliers to implement corrective actions.</li><li>
Process improvement: Collaborating with suppliers to identify opportunities for process improvements and implement solutions to enhance product quality.</li><li>
Technical support: Providing technical expertise to suppliers regarding product specifications, quality standards, and testing methods.</li><li>
Advise and support Quality Inspectors on day-to-day issues with incoming materials.</li><li>
Documentation and reporting: Maintaining detailed records of supplier performance, quality issues, corrective actions, and audit findings. Create, issue, and complete Supplier Corrective Action requests.</li><li>
New product introduction support: Working with the engineering team to ensure new suppliers and components meet quality requirements during product development.</li><li>
Supplier performance monitoring: Tracking key performance indicators (KPIs) to evaluate supplier quality and identify areas for improvement.</li></ul>
Requirements:<p></p><p><b><br>
Education / Certifications</b></p><ul><li>
High School Diploma or GED required</li><li>
ASQ / CQE certifications</li><li>
Six Sigma Certified Green or Black Belt</li></ul><p><b>
Job Requirements</b></p><ul><li>
Strong understanding of quality management systems (QMS) and industry standards.</li><li>
Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.</li><li>
Experience with statistical analysis tools (e.g., SPC) to identify trends and root causes.</li><li>
Excellent communication and interpersonal skills to effectively collaborate with suppliers and internal teams.</li><li>
Ability to conduct thorough audits and assessments.</li><li>
Problem-solving and analytical skills to identify root causes and implement effective solutions.</li><li>
Proficient in data analysis and report generation.</li><li>
Minimum of 5 years&rsquo; experience in Quality Engineering within a Medical Device Manufacturing environment.</li><li>
Experience in nonconforming material and CAPA methodologies/systems preferred.</li><li>
Familiar with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).</li><li>
High sense of urgency and commitment to execution.</li><li>
Applies continuous improvement principles in the development of the quality system.</li><li>
Driven, energetic, self-assured professional with high personal integrity.</li><li>
Knowledge of analytical techniques and statistical analysis.</li></ul></div>

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