Principal Quality Engineer

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.
• Analyze 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.
• ASQ 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.