Principal Quality Engineer

Principal Quality Engineer

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence. Responsibilities include:

• Leading quality engineering activities supporting product development, manufacturing, and sustaining engineering.
• Developing and implementing quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
• Driving root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies.
• Leading risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
• Reviewing and approving engineering change orders (ECOs), design documentation, validation protocols, and quality records.
• Supporting design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF).
• Analyzing quality metrics and implementing continuous improvement initiatives using Lean Six Sigma and statistical tools.
• Leading process validation activities including IQ, OQ, PQ, and process capability studies.
• Collaborating with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
• Providing technical leadership during internal, customer, and regulatory audits.
• Mentoring and coaching Quality Engineers and cross-functional teams on quality best practices.
• Supporting supplier qualification, supplier audits, and supplier quality improvement initiatives.
• Ensuring compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Requirements include:

• Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related discipline).
• 8+ years of Quality Engineering experience in a regulated manufacturing environment.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, Client, and change management.
• Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis, SPC, MSA, and capability studies.
• Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.
• Experience leading cross-functional projects and mentoring engineering teams.
• Strong written, verbal, and presentation skills.

Preferred Qualifications include:

• Master's degree in Engineering or related technical field.
• ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt.
• Experience in medical devices, pharmaceuticals, biotechnology, aerospace, automotive, or other highly regulated industries.
• Experience supporting FDA inspections and ISO certification audits.
• Knowledge of validation documentation, statistical software (Minitab), and quality management systems.