Job Description: 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.
Responsibilities: - Provide technical leadership and mentorship to Quality Engineers and cross-functional teams.
- Lead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.
- Drive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.
- Lead CAPA development, implementation, effectiveness verification, and closure activities.
- Ensure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.
- Support product development activities including Design Controls, Risk Management, Verification & Validation, and Design Transfer.
- Develop and maintain quality plans, inspection strategies, control plans, and quality metrics.
- nalyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.
- Lead internal and external audits, supplier audits, and regulatory inspections.
- Collaborate with Manufacturing, R&D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.
- Review and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.
- Support supplier quality management activities including supplier qualification and performance monitoring.
- Drive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.
- Review engineering changes and assess quality and regulatory impacts.
- Present quality performance metrics and recommendations to senior management.
Requirements: - Bachelor's degree in engineering, Quality, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field.
- 8-15+ years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology, Aerospace, or highly regulated industries.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP, and quality management systems.
- Extensive experience with CAPA, complaint handling, investigations, risk management, and process validation.
- Experience leading audits and interacting with regulatory agencies.
- Strong statistical analysis and problem-solving skills.
- Proficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.
- Excellent technical writing, communication, and leadership skills.
Preferred Qualifications: - Master's degree in engineering or related field.
- SQ Certifications such as:
- Certified Quality Engineer (CQE)
- Certified Six Sigma Black Belt (CSSBB)
- Certified Manager of Quality/Organizational Excellence (CMQ/OE)
- Experience with medical device product lifecycle management.
- Experience supporting global manufacturing operations.
Key Skills: - Quality Systems Management.
- CAPA Leadership.
- Root Cause Analysis.
- Design Controls.
- Risk Management (ISO 14971).
- Process Validation.
- Statistical Analysis.
- Supplier Quality.
