Qureos Mentor

Katalyst Healthcares & Life Sciences

<div><div><b>Job Description:</b>
</div><div>Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and company policies and procedures.<br>
<b>Responsibilities:</b>
<ul><li>Perform routine testing (dissolution, assay/degradant, content uniformity and ID) of drug products in a cGMP laboratory.
</li><li>Complete all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
</li><li>Enter data into laboratory information system and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
</li><li>Operate and maintain all analytical instrumentation and equipment as per established procedures; perform basic troubleshooting.
</li><li>Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
</li><li>Aid other group members as required.
</li><li>Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
</li><li>Re-stock chemicals and consumables used in analysis.
</li><li>Performs other related assignments and duties as required and assigned.
</li></ul><p><b>Requirements:</b>
</p><ul><li>The incumbent must have a BA or BS degree in Chemistry or closely related science.
</li><li>Minimum of 1-year relevant experience preferred.
</li><li>Understanding of analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy UV/Vis, NIR, IR, or AA/AE).
</li><li>Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.
</li><li><b>Physical and Environmental:</b>
</li><li>Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
</li><li>Lift and maneuver equipment and materials weighing up to 20 pounds.
</li><li>Take samples which may require stretching, bending, or twisting to remove product from the equipment and/or drums.
</li><li>Use small hand and power tools to perform incidental maintenance.
</li><li>Perform cleaning and assembly/disassembly on laboratory equipment which may require pulling, pushing, or twisting to remove equipment shields, parts and panels. Equipment and parts could weigh up to 20 pounds. Also requires operation of industrial hose (water) and physical exertion (repetitive wiping, rubbing and scrubbing) to clean equipment and laboratory surfaces.</li></ul></div></div>

Quality Control Analyst

<div><b>Job Description:</b><br>
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.<br>
<b>Responsibilities:</b>
<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><p><b>Requirements:</b>
</p><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><p><b>Keys:</b>
</p><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><b>Responsibilities:</b>
<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><p><b>Requirements:</b>
</p><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><b>Job Description:</b><br>
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<b> .</b><br>
<b>Responsibilities:</b>
<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><p><b>Requirements:</b>
</p><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><p><b>Preferred Experience:</b>
</p><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<b> .</b>
</li></ul><p><b>Work Environment:</b>
</p><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><p><b>Physical Requirements:</b>
</p><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><p></p>

<div><b>Job Description:</b><br>
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.<br>
<b>Responsibilities:</b>
<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"><b>Requirements:</b><b>
</b></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"><b>Preferred Qualifications:</b><b>
</b></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"><b>Key Skills:</b><b>
</b></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><b>Job Description:
</b><br>
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<b> .</b><br>
<b>Responsibilities:</b>
<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><p><b>Requirements:</b>
</p><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><p><b>Preferred Experience:</b>
</p><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<b> .</b>
</li></ul><p><b>Work Environment:</b>
</p><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><p><b>Physical Requirements:</b>
</p><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><p></p>

Join Katalyst Healthcares & Life Sciences and explore 6   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

Quality Control Analyst

Supplier Quality Engineer

Quality Engineer

Quality Engineer

Principal Quality Engineer

Quality Engineer