Principal Quality Engineer

Position SummaryThe Principal Quality Engineer is responsible for providing technical leadership and quality engineering expertise across product development, new product introduction (NPI), manufacturing, and post-market activities. This role serves as a key quality representative supporting design control, process validation, risk management, regulatory compliance, and continuous improvement initiatives for Class II and/or Class III medical devices. The Principal Quality Engineer partners with cross-functional teams to ensure products and manufacturing processes meet applicable FDA, ISO 13485, and global regulatory requirements while driving quality excellence throughout the product lifecycle. Key ResponsibilitiesQuality & Regulatory LeadershipServe as a quality subject matter expert (SME) for product development, manufacturing, and sustaining engineering activities.Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, and other applicable regulatory requirements.Support internal audits, external audits, supplier audits, and regulatory inspections.Lead quality system improvements to enhance compliance, efficiency, and effectiveness.Product Development & Design AssurancePartner with R&D teams throughout product development and design transfer activities.Ensure compliance with Design Controls and risk management requirements.Review and approve design documentation, including requirements, verification/validation protocols, and technical reports.Facilitate Design Reviews and provide guidance on quality and regulatory expectations.Support design changes, engineering changes, and product lifecycle management activities.Risk ManagementLead and facilitate risk management activities in accordance with ISO 14971.Develop and maintain risk management files, including Hazard Analyses, DFMEAs, PFMEAs, and risk-benefit assessments.Drive mitigation strategies and verify effectiveness of implemented controls.Validation & QualificationLead process validation activities including IQ, OQ, and PQ execution.Develop and approve validation protocols and reports for manufacturing processes, equipment, software, test methods, and inspection systems.Support equipment qualification, process characterization, and statistical analysis activities.Ensure validation activities meet applicable regulatory and quality requirements.Manufacturing Quality SupportProvide ongoing quality engineering support to manufacturing operations.Lead investigations for nonconformances, customer complaints, CAPAs, and audit findings.Utilize structured problem-solving methodologies including DMAIC, 8D, Fishbone Analysis, and 5 Whys.Analyze quality metrics and trend data to identify opportunities for continuous improvement.Drive yield improvement, defect reduction, and process capability enhancement initiatives.Supplier QualityCollaborate with suppliers to ensure component and material quality.Support supplier qualification, monitoring, audits, and corrective action activities.Review supplier quality data and drive improvement plans when necessary.Cross-Functional LeadershipLead complex quality initiatives spanning multiple departments and locations.Mentor and develop Quality Engineers and quality professionals.Influence organizational quality strategy through technical expertise and leadership.Present quality performance, risk assessments, and project status updates to senior leadership.Required QualificationsBachelor's degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, or related technical field.10+ years of quality engineering experience within the medical device industry.Strong knowledge of FDA regulations, ISO 13485, and medical device quality systems.Demonstrated experience with design controls, process validation, and risk management.Experience leading CAPA investigations and root cause analysis activities.Proficiency with statistical analysis, process capability studies, and quality improvement methodologies.Proven ability to lead cross-functional teams and influence stakeholders without direct authority.Excellent written, verbal, and presentation skills.Preferred QualificationsMaster's degree in Engineering or related technical discipline.ASQ Certified Quality Engineer (CQE), Certified Six Sigma Black Belt, or equivalent certification.Experience supporting Class III implantable or combination products.Experience with manufacturing automation, inspection systems, and software validation.Knowledge of global regulatory requirements including EU MDR.Experience leading regulatory inspections and customer audits.Key CompetenciesQuality Systems LeadershipDesign AssuranceProcess Validation (IQ/OQ/PQ)Risk Management (ISO 14971)CAPA & Root Cause AnalysisStatistical Analysis & Data InterpretationSupplier Quality ManagementRegulatory ComplianceCross-Functional CollaborationContinuous Improvement & Lean Six Sigma