Principal Quality Engineer
Position Summary
The Principal Quality Engineer is responsible for providing technical leadership and quality engineering expertise across product development, new product introduction (NPI), manufacturing, and post-market activities. This role serves as a key quality representative supporting design control, process validation, risk management, regulatory compliance, and continuous improvement initiatives for Class II and/or Class III medical devices. The Principal Quality Engineer partners with cross-functional teams to ensure products and manufacturing processes meet applicable FDA, ISO 13485, and global regulatory requirements while driving quality excellence throughout the product lifecycle.
Key Responsibilities
Quality & Regulatory Leadership
- Serve as a quality subject matter expert (SME) for product development, manufacturing, and sustaining engineering activities.
- Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, and other applicable regulatory requirements.
- Support internal audits, external audits, supplier audits, and regulatory inspections.
- Lead quality system improvements to enhance compliance, efficiency, and effectiveness.
Product Development & Design Assurance
- Partner with R&D teams throughout product development and design transfer activities.
- Ensure compliance with Design Controls and risk management requirements.
- Review and approve design documentation, including requirements, verification/validation protocols, and technical reports.
- Facilitate Design Reviews and provide guidance on quality and regulatory expectations.
- Support design changes, engineering changes, and product lifecycle management activities.
Risk Management
- Lead and facilitate risk management activities in accordance with ISO 14971.
- Develop and maintain risk management files, including Hazard Analyses, DFMEAs, PFMEAs, and risk-benefit assessments.
- Drive mitigation strategies and verify effectiveness of implemented controls.
Validation & Qualification
- Lead process validation activities including IQ, OQ, and PQ execution.
- Develop and approve validation protocols and reports for manufacturing processes, equipment, software, test methods, and inspection systems.
- Support equipment qualification, process characterization, and statistical analysis activities.
- Ensure validation activities meet applicable regulatory and quality requirements.
Manufacturing Quality Support
- Provide ongoing quality engineering support to manufacturing operations.
- Lead investigations for nonconformances, customer complaints, CAPAs, and audit findings.
- Utilize structured problem-solving methodologies including DMAIC, 8D, Fishbone Analysis, and 5 Whys.
- Analyze quality metrics and trend data to identify opportunities for continuous improvement.
- Drive yield improvement, defect reduction, and process capability enhancement initiatives.
Supplier Quality
- Collaborate with suppliers to ensure component and material quality.
- Support supplier qualification, monitoring, audits, and corrective action activities.
- Review supplier quality data and drive improvement plans when necessary.
Cross-Functional Leadership
- Lead complex quality initiatives spanning multiple departments and locations.
- Mentor and develop Quality Engineers and quality professionals.
- Influence organizational quality strategy through technical expertise and leadership.
- Present quality performance, risk assessments, and project status updates to senior leadership.
Required Qualifications
- Bachelor's degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, or related technical field.
- 10+ years of quality engineering experience within the medical device industry.
- Strong knowledge of FDA regulations, ISO 13485, and medical device quality systems.
- Demonstrated experience with design controls, process validation, and risk management.
- Experience leading CAPA investigations and root cause analysis activities.
- Proficiency with statistical analysis, process capability studies, and quality improvement methodologies.
- Proven ability to lead cross-functional teams and influence stakeholders without direct authority.
- Excellent written, verbal, and presentation skills.
Preferred Qualifications
- Master's degree in Engineering or related technical discipline.
- ASQ Certified Quality Engineer (CQE), Certified Six Sigma Black Belt, or equivalent certification.
- Experience supporting Class III implantable or combination products.
- Experience with manufacturing automation, inspection systems, and software validation.
- Knowledge of global regulatory requirements including EU MDR.
- Experience leading regulatory inspections and customer audits.
Key Competencies
- Quality Systems Leadership
- Design Assurance
- Process Validation (IQ/OQ/PQ)
- Risk Management (ISO 14971)
- CAPA & Root Cause Analysis
- Statistical Analysis & Data Interpretation
- Supplier Quality Management
- Regulatory Compliance
- Cross-Functional Collaboration
- Continuous Improvement & Lean Six Sigma
FAQs
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