Qureos Mentor

Katalyst Healthcares & Life Sciences

<div>Job Description: 
The Supplier Engineer II will focus on value improvement projects, new product introduction, &amp; sustaining projects for the Connectors and Cable Assemblies category team. This role partners with cross-functional groups to resolve supplier-related issues, while improving supplier performance, mitigating risks for supplied materials, and driving strategies to support supply chain objectives. 
Responsibilities:
<ul><li>Working with suppliers globally to understand assembly and finished good manufacturing processes and acts as technical expert to ensure repeatable and reproducible quality during the life of the product.
</li><li>Interfacing with suppliers and category team members to support investigation of supplied material issues or supply constraints.
</li><li>Collaborating with R&amp;D, manufacturing, and process development teams on electrical and mechanical design requirements for new product development
</li><li>Partnering with manufacturing, quality, and/or sustaining R&amp;D/DA/PM to execute changes initiated by BSC or by the Suppliers, such as improvement projects, supplier capability, capacity projects, and compliance projects
</li><li>Supporting supplier engineering work content for projects, including component qualification, test method validation creation, and change assessments; communicate emerging issues and recovery action plans
</li><li>Identifying and executing material cost reduction projects to meet Plant, Division, and Category goals.
</li></ul>Requirements:
<ul><li>Bachelor's degree in engineering or related discipline.
</li><li>Minimum of 1 year of technical experience supporting complex mechanical or electrical systems.
</li><li>Self-driven and self-motivated to learn and apply knowledge to produce results.
</li><li>Organized and detail-oriented; ability to prioritize and manage multiple projects.
</li><li>Strong communication and interpersonal skills with ability to develop internal and external relationships.
</li><li>Effective problem-solving and critical thinking analytical skills; results-driven.
</li><li>Working knowledge of statistical methods, six sigma methodologies, and problem-solving methodologies.
</li><li>Experience working in medical device or a similar GMP environment.
</li><li>Ability to work with cross-functional teams to drive project deliverables.
</li><li>Minitab experience is a plus.
</li></ul>Keys:
<ul><li>Supplier quality, selection and performance.
</li><li>NPD and component qualification.
</li><li>Connectors and cabling.</li></ul></div>

Supplier Quality Engineer

<div>Responsibilities:
<ul><li>The manager is seeking a new batch of candidates to review. Highlighted below is where some of the individuals from the first round of interviews fell short.
</li><li>Technical depth in TMV, risk management and V&amp;V. (Seeking experience both developing and executing the activities, not just being part of a team).
</li><li>Experience being part of integration efforts and/or major remediation efforts Some of the candidates, they spoke about TMV but they couldn't get into the technical depth so we are looking for those who have more experience
</li></ul>Requirements:
<ul><li>Bachelors in Engineering or related.
</li><li>4+ years of experience.
</li><li>Experience in NPD or Design Quality (21 CFR 820).
</li><li>Experience with design integration/DHF remediation.
</li><li>Experience with vascular devices (catheters, stents, guidewires etc.) is a huge plus.
</li><li>Design integration, design remediation, implementation of DFM principles and supporting risk management architecture.</li></ul></div>

Quality Engineer

<div><div>Job Description: 
We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards . 
Responsibilities:
<ul><li>Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
</li><li>Conduct complaint investigations and perform detailed root cause analysis.
</li><li>Analyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
</li><li>Prepare investigation summaries, reports, and recommendations based on analysis.
</li><li>Review existing investigation reports and identify GMP compliance gaps.
</li><li>Support development and implementation of corrective and preventive actions (CAPA).
</li><li>Drive continuous improvement initiatives and process control activities.
</li><li>Conduct data analysis using statistical and quality tools.
</li><li>Support maintenance activities for existing product lines and quality systems.
</li><li>Collaborate cross-functionally to improve product quality and compliance standards.
</li></ul>Requirements:
<ul><li>Bachelor's degree in engineering (B.E./B.Tech or equivalent).
</li><li>1 3 years of experience in the Medical Device industry.
</li><li>Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
</li><li>Experience in complaint handling, investigations, and root cause analysis.
</li><li>Familiarity with CAPA processes and quality systems.
</li><li>Strong analytical and problem-solving skills.
</li><li>Experience with statistical tools/software such as Minitab is a plus.
</li><li>Ability to read and interpret technical drawings and engineering documentation.
</li><li>Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
</li><li>Ability to manage multiple tasks and projects effectively.
</li></ul>Preferred Experience:
<ul><li>Experience with ANSI/ISO/ASQC standards.
</li><li>Exposure to continuous improvement methodologies and process controls.
</li><li>Knowledge of medical device regulatory environments and compliance practices .
</li></ul>Work Environment:
<ul><li>FDA-regulated manufacturing environment.
</li><li>Temperature and humidity-controlled workspace.
</li><li>May require use of static-protective equipment while in designated work areas.
</li></ul>Physical Requirements:
<ul><li>Ability to sit for extended periods.
</li><li>Good hand-eye coordination and dexterity.
</li><li>Ability to lift up to 40 lbs when required.</li></ul></div></div>

<div>Job Description: 
We are seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives in a regulated manufacturing environment. This role provides technical leadership for quality systems, product quality improvements, risk management, CAPA activities, process validation, and compliance programs. The Principal Quality Engineer serves as a subject matter expert, partnering with cross-functional teams to ensure products meet customer, regulatory, and business requirements while driving continuous improvement and operational excellence. 
Responsibilities:
<ul><li>Provide technical leadership and mentorship to Quality Engineers and cross-functional teams.
</li><li>Lead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.
</li><li>Drive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.
</li><li>Lead CAPA development, implementation, effectiveness verification, and closure activities.
</li><li>Ensure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.
</li><li>Support product development activities including Design Controls, Risk Management, Verification &amp; Validation, and Design Transfer.
</li><li>Develop and maintain quality plans, inspection strategies, control plans, and quality metrics.
</li><li>Analyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.
</li><li>Lead internal and external audits, supplier audits, and regulatory inspections.
</li><li>Collaborate with Manufacturing, R&amp;D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.
</li><li>Review and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.
</li><li>Support supplier quality management activities including supplier qualification and performance monitoring.
</li><li>Drive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.
</li><li>Review engineering changes and assess quality and regulatory impacts.
</li><li>Present quality performance metrics and recommendations to senior management.
</li></ul><h3 class="jobSectionHeader">Requirements:
</h3><ul><li>Bachelor's degree in engineering, Quality, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field.
</li><li>8 15+ years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology, Aerospace, or highly regulated industries.
</li><li>Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP, and quality management systems.
</li><li>Extensive experience with CAPA, complaint handling, investigations, risk management, and process validation.
</li><li>Experience leading audits and interacting with regulatory agencies.
</li><li>Strong statistical analysis and problem-solving skills.
</li><li>Proficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.
</li><li>Excellent technical writing, communication, and leadership skills.
</li></ul><h3 class="jobSectionHeader">Preferred Qualifications:
</h3><ul><li>Master's degree in engineering or related field.
</li><li>ASQ Certifications such as:
<ul><li>Certified Quality Engineer (CQE)
</li><li>Certified Six Sigma Black Belt (CSSBB)
</li><li>Certified Manager of Quality/Organizational Excellence (CMQ/OE)
</li></ul></li><li>Experience with medical device product lifecycle management.
</li><li>Experience supporting global manufacturing operations.
</li></ul><h3 class="jobSectionHeader">Key Skills:
</h3><ul><li>Quality Systems Management.
</li><li>CAPA Leadership.
</li><li>Root Cause Analysis.
</li><li>Design Controls.
</li><li>Risk Management (ISO 14971).
</li><li>Process Validation.
</li><li>Statistical Analysis.
</li><li>Supplier Quality.</li></ul></div>

Principal Quality Engineer

<div>Job Description:
 
We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards . 
Responsibilities:
<ul><li>Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
</li><li>Conduct complaint investigations and perform detailed root cause analysis.
</li><li>Analyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
</li><li>Prepare investigation summaries, reports, and recommendations based on analysis.
</li><li>Review existing investigation reports and identify GMP compliance gaps.
</li><li>Support development and implementation of corrective and preventive actions (CAPA).
</li><li>Drive continuous improvement initiatives and process control activities.
</li><li>Conduct data analysis using statistical and quality tools.
</li><li>Support maintenance activities for existing product lines and quality systems.
</li><li>Collaborate cross-functionally to improve product quality and compliance standards.
</li></ul>Requirements:
<ul><li>Bachelor's degree in engineering (B.E./B.Tech or equivalent).
</li><li>1 3 years of experience in the Medical Device industry.
</li><li>Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
</li><li>Experience in complaint handling, investigations, and root cause analysis.
</li><li>Familiarity with CAPA processes and quality systems.
</li><li>Strong analytical and problem-solving skills.
</li><li>Experience with statistical tools/software such as Minitab is a plus.
</li><li>Ability to read and interpret technical drawings and engineering documentation.
</li><li>Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
</li><li>Ability to manage multiple tasks and projects effectively.
</li></ul>Preferred Experience:
<ul><li>Experience with ANSI/ISO/ASQC standards.
</li><li>Exposure to continuous improvement methodologies and process controls.
</li><li>Knowledge of medical device regulatory environments and compliance practices .
</li></ul>Work Environment:
<ul><li>FDA-regulated manufacturing environment.
</li><li>Temperature and humidity-controlled workspace.
</li><li>May require use of static-protective equipment while in designated work areas.
</li></ul>Physical Requirements:
<ul><li>Ability to sit for extended periods.
</li><li>Good hand-eye coordination and dexterity.
</li><li>Ability to lift up to 40 lbs when required.</li></ul></div>

Join Katalyst Healthcares & Life Sciences and explore 5   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Katalyst Healthcares & Life Sciences

About Company

Supplier Quality Engineer

Quality Engineer

Quality Engineer

Principal Quality Engineer

Quality Engineer