Principal Quality engineer

Responsibilities

• Provide technical leadership for quality engineering activities across product development, manufacturing, and sustaining engineering.
• Lead Quality planning for New Product Introduction (NPI), design transfer, process validation, and manufacturing readiness.
• Develop, implement, and continuously improve Quality Management System (QMS) processes in compliance with regulatory and industry standards.
• Lead investigations for non-conformances, customer complaints, and quality issues using structured root cause analysis and drive effective CAPA implementation.
• Develop and maintain risk management documentation, including Design and Process FMEAs, hazard analysis, and risk mitigation plans.
• Support qualification and validation activities, including IQ/OQ/PQ, process validation, and equipment qualification.
• Partner with Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and Operations to resolve complex quality issues.
• Analyze quality metrics and statistical data to identify trends and implement data-driven process improvements.
• Lead supplier quality initiatives, supplier qualification, audits, and corrective action programs.
• Ensure compliance with FDA regulations, ISO standards, and applicable global regulatory requirements.
• Support internal, customer, and regulatory audits and ensure timely closure of audit observations.
• Mentor and coach Quality Engineers while serving as a technical resource for quality-related decisions.
• Drive Lean, Six Sigma, and continuous improvement initiatives to improve product quality, reduce defects, and increase operational efficiency.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, Quality Engineering, or a related technical discipline.
• 10+ years of Quality Engineering experience in a regulated industry such as Medical Devices, Pharmaceuticals, Biotechnology, Aerospace, or Advanced Manufacturing.
• Strong knowledge of Quality Management Systems (QMS), quality engineering principles, and regulatory compliance.
• Experience with ISO 13485 and/or ISO 9001 Quality Management Systems.
• Knowledge of FDA 21 CFR Part 820/QMSR and applicable global quality regulations.
• Hands-on experience with CAPA, Non-Conformance (NC), Complaint Handling, Risk Management, FMEA, and Root Cause Analysis.
• Experience supporting design transfer, process validation, manufacturing support, and New Product Introduction (NPI).
• Proficiency in statistical methods including SPC, MSA, DOE, capability analysis, and data-driven decision making.
• Experience leading internal, supplier, customer, and regulatory audits.
• Excellent leadership, communication, and stakeholder management skills.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt certification.
• Experience with SAP, Minitab, SmartSolve, TrackWise, or other Quality Management Systems.
• Knowledge of Lean Manufacturing, Kaizen, and continuous improvement methodologies.
• Experience leading global or cross-functional quality initiatives.
• Strong project management and mentoring experience.