Principal Quality Engineer
Position Summary
The Principal Quality Engineer serves as a technical leader within the Quality organization, providing strategic and hands-on support for product development, manufacturing operations, process validation, and quality system compliance. This role partners with cross-functional teams to ensure products are designed, manufactured, and maintained in compliance with FDA regulations, ISO 13485 requirements, and company quality standards.
The Principal Quality Engineer will lead complex quality initiatives, drive continuous improvement efforts, mentor engineering staff, and act as a subject matter expert for risk management, validation, investigations, and quality systems.
Essential Responsibilities
- Lead quality engineering activities supporting product development, design transfer, manufacturing, and post-market activities.
- Serve as a quality representative on cross-functional project teams for new product introductions, process changes, and manufacturing transfers.
- Provide technical leadership for process validation activities, including IQ, OQ, PQ, and continued process verification.
- Lead root cause investigations using structured problem-solving methodologies and ensure effective implementation of corrective and preventive actions (CAPA).
- Facilitate risk management activities including Hazard Analysis, FMEA, risk assessments, and risk-benefit evaluations.
- Develop and maintain quality plans, control plans, inspection strategies, and process monitoring methodologies.
- Analyze quality metrics and process performance data to identify trends and drive continuous improvement initiatives.
- Support development, qualification, and validation of test methods and inspection systems.
- Partner with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and Operations to resolve quality issues and improve product performance.
- Lead internal and external audits, including FDA inspections, ISO audits, customer audits, and supplier assessments.
- Review and approve engineering changes, nonconformances, deviations, validations, and quality documentation.
- Support supplier quality initiatives including supplier qualification, supplier audits, performance monitoring, and supplier corrective actions.
- Provide technical oversight of statistical methods including SPC, process capability analysis, sampling plans, and data-driven decision making.
- Mentor Quality Engineers and provide guidance on quality tools, regulations, and best practices.
- Act as a subject matter expert on quality system requirements and compliance expectations.
Qualifications
Education
- Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline required.
- Master's degree preferred.
Experience
- 10+ years of quality engineering experience within the medical device industry.
- Experience working within FDA-regulated and ISO 13485-certified environments.
- Demonstrated experience supporting manufacturing processes and product development activities.
- Experience leading complex quality initiatives and cross-functional projects.
- Prior experience serving as a technical mentor or informal leader preferred.
FAQs
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