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