Quality Engineer

Prospect Life Sciences; Denver (CO); On-site; USD 85,000 - 120,000; Full time

Job summary

Prospect Life Sciences in Denver seeks a Quality Engineer to oversee product and process quality within FDA-regulated environments. You will manage CAPA, nonconforming materials, investigations, and inspections across the QMS.

You will collaborate with Manufacturing, Development, Supply Chain, and QA teams to ensure regulatory compliance, process controls, and ongoing improvement initiatives. A BS in engineering or life sciences and 5+ years' experience are preferred.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required.
• Minimum of five (5) years of progressive experience in FDA-regulated medical device Quality Management Systems.
• Demonstrated experience implementing and maintaining Quality Management Systems compliant with FDA QSR, ISO 13485:2016, ISO 14971.
• Experience supporting CAPA, nonconforming materials, supplier quality, complaint investigations, sterilization, inspections, process validation, risk management, and internal audits.
• Experience planning, conducting, or supporting internal, supplier, and process audits.

Responsibilities

• Administer CAPA program, including monitoring, investigation support, effectiveness verification, and compliance with procedures and regulatory requirements.
• Manage product returns, servicing activities, and complaint investigations.
• Support internal, supplier, customer, and regulatory audits including preparation and follow-up.
• Conduct failure investigations to identify root causes and corrective actions.
• Support supplier qualification, monitoring, and continuous improvement activities.
• Maintain product sterilization controls, environmental monitoring programs, and cleanroom controls.
• Assist with inspections, process validation, PFMEA development, and risk management.

Skills

Quality Engineer

CAPA

QMS

FDA regulatory

Audits

Education

Bachelor's degree in Engineering or Life Sciences

Tools

eQMS

ERP systems

Microsoft Office

Job description

The Quality Engineer is directly responsible for overseeing product and process quality. The Quality Engineer maintains the following quality system functions: CAPA, product returns and servicing, nonconforming materials, receiving, in-process, and final inspections, product complaints, process environmental controls, and sterilization controls.

The position reports directly to the Quality Assurance Manager.

Key Accountabilities

Quality System Execution – 60%

Accountable for executing and maintaining assigned Quality Management System (QMS) processes to ensure regulatory compliance, product quality, process effectiveness, and continuous improvement. Supports manufacturing, supplier quality, sterilization, environmental controls, CAPA, complaint investigations, inspections, and risk management while ensuring compliance with applicable quality system requirements.

Cross-Functional Operational Support – 10%

Accountable for providing technical quality engineering support to Manufacturing, Product Development, Supply Chain, and Operations by identifying quality risks, implementing process controls, supporting validation activities, resolving quality issues, coaching associates, and promoting effective quality practices throughout the organization.

Accountable for supporting assigned client projects through effective quality engineering execution, timely completion of quality deliverables, accurate reporting of quality metrics, continuous improvement initiatives, and implementation of best practices that improve product quality, regulatory compliance, operational efficiency, and customer satisfaction.

Primary Responsibilities

Quality System Execution

1. Administer the CAPA program, including monitoring, investigation support, effectiveness verification, and compliance with internal procedures and regulatory requirements.
2. Manage product returns, servicing activities, and complaint investigations in accordance with established Quality System procedures.
3. Support internal, supplier, customer, and regulatory audits, including preparation, participation, response development, and follow-up activities.
4. Conduct failure investigations involving nonconforming materials, scrap, CAPAs, complaints, and manufacturing quality issues to identify root causes and corrective actions.
5. Support supplier qualification, monitoring, and continuous improvement activities to ensure supplier quality and regulatory compliance.
6. Maintain product sterilization controls, environmental monitoring programs, cleanroom controls, and other assigned Quality System processes.
7. Support receiving, in-process, and final inspection activities while ensuring compliance with inspection procedures and acceptance criteria.
8. Support process validation, PFMEA development, manufacturing readiness, and risk management activities in collaboration with Product Development and Operations.
9. Monitor quality records, including inspection records, lot history records, calibration records, sterilization records, and other quality documentation to ensure completeness and compliance.
10. Recommend and implement improvements that enhance Quality System effectiveness, product quality, regulatory compliance, and operational efficiency.

Cross-Functional Operational Support

1. Coach and train associates on Quality System procedures, process controls, inspection techniques, and quality best practices.
2. Provide technical quality engineering support to Manufacturing, Product Development, Supply Chain, and Operations to resolve quality issues and improve process performance.
3. Collaborate with cross-functional teams to support product development, design transfer, validation activities, and risk management throughout the product lifecycle.
4. Promote effective communication and collaboration across functional teams to support Quality objectives and organizational success.
5. Actively pursue self-initiated professional development opportunities beyond PLS-sponsored programs to enhance technical knowledge, quality engineering capability, and organizational impact.

Client Projects

1. Support assigned client projects by completing quality engineering deliverables in accordance with project schedules, budgets, regulatory requirements, and customer expectations.
2. Report and analyze quality metrics, environmental monitoring data, and quality trends to identify opportunities for continuous improvement.
3. Support project invoicing activities by completing required EOM/PR documentation accurately and on time.
4. Participate in client meetings, technical discussions, process implementation reviews, validation activities, and project retrospectives as assigned.
5. Drive continuous improvement initiatives by implementing best practices, supporting Lean and quality improvement activities, and incorporating client and internal feedback to improve products, processes, and customer satisfaction.

Education and Experience

1. Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required.
2. Minimum of five (5) years of progressive experience in FDA-regulated medical device Quality Management Systems.
3. Demonstrated experience implementing and maintaining Quality Management Systems compliant with the FDA Quality Management System Regulation (QMSR), formerly 21 CFR Part 820 (QSR), ISO 13485:2016, ISO 14971, and applicable domestic and international regulatory requirements.
4. Experience supporting CAPA, nonconforming materials, supplier quality, complaint investigations, sterilization, inspections, process validation, risk management, and internal audits.
5. Experience planning, conducting, or supporting internal, supplier, and process audits.
6. Qualified, or capable of becoming qualified within six (6) months of hire, as a PLS Internal Quality Auditor in accordance with ISO 13485:2016 and the PLS Internal Audit Procedure.

Other Qualifications

1. Excellent analytical, technical writing, communication, organizational, and problem-solving skills.
2. Proficient in Microsoft Office applications, electronic Quality Management Systems (eQMS), and ERP systems.
3. Experience working in a Contract Development and Manufacturing Organization (CDMO) environment is preferred.
4. Experience implementing Lean, Six Sigma, EOS, or other continuous improvement methodologies is preferred.
5. Ability to effectively collaborate with cross-functional teams and independently manage multiple priorities.

Preferred Professional Certifications

1. ASQ Certified Quality Engineer (CQE) (most valuable for this position)
2. ASQ Certified Quality Auditor (CQA)
3. ISO 13485:2016 Internal Auditor or Lead Auditor Certification
4. Medical Device Single Audit Program (MDSAP) Auditor Training
5. Certified Reliability Engineer (CRE) (optional but valuable if supporting process validation and failure investigations)