Principal Engineer I, Quality Systems

Job Title: Principal Engineer, Quality Systems

• Principal Engineer I, Quality Systems
• Principal Engineer II, Quality Systems
• Principal Engineer III, Quality Systems

Role Level: Individual Contributor

Supervisor/Manager Title: Director, Global Quality and Compliance

Job Location & Environment: Irvine, CA – Corporate Office

Job Description Summary: The Principal Engineer, Quality Systems is responsible for Quality Systems and Quality Engineering tasks associated with new product development and commercialization in compliance with global regulatory requirements and industry standards (FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP) and alignment with business objectives. Support various QMS initiatives and processes, including CAPA, non-conformance, change control, management review, quality metrics, and inspection readiness.

Job Responsibilities:

• Collaborate with cross-functional teams such as Regulatory, Manufacturing Operations, and R&D to support the Quality Management System and core processes, eQMS system enhancements and validation activities, and ensure QMS requirements are embedded through product lifecycle.
• Promote proactive quality culture and support training on quality system fundamentals and practices across Quality and cross-functional groups.
• Lead Quality System activities including CAPAs, Nonconformance Reports (NCRs), Material Review Board (MRB), internal audits, management reviews, and quality metrics trending to drive robust corrective and preventive actions.
• Support FDA inspections, Notified Body audits, supplier audits, and internal audits, including investigation and timely closure of audit findings.
• Support technology innovation and digital transformation initiatives by evaluating and implementing modern analytical tools, automation, and advance quality monitoring systems.
• Lead harmonization of quality KPIs across all sites globally
• Support software validation activities including, but not limited to, authoring relevant verification/validation documentation such as user/functional requirements specifications, vendor assessments, risk assessments, testing plans, protocols/scripts, and reports, executing verification/validation testing, and developing procedures related to specific software use.
• Support RGA process compliance including receipt, evaluation, investigation, and documentation of returned goods while ensuring appropriate linkage to complaints, traceability requirements, and QMS records are maintained.
• Act as SME for all quality system processes improvement initiatives
• Provide technical guidance to quality specialists and junior engineers supporting the various quality system elements.

Required Education and Experience:

• Bachelor of Science degree in Biomedical Engineering, or equivalent engineering discipline required. Master of Science degree preferred.
• Minimum of 10+ years of experience or Master’s degree plus eight (8) years of experience in the medical device or pharmaceutical industry is required.
• Expert knowledge and understanding of principles, theories, and concepts relevant to Quality Systems and/or Quality Engineering.
• Quality Engineering experience in production and/or R&D support is required.
• Expert problem-solving, organization, analytical, and critical thinking skills.
• Direct experience in regulated manufacturing environment and knowledge of regulations and standards: 21 CFR Part 820, ISO 13485, ISO 14971
• Knowledge of and adherence to cleanroom medical device hygiene and manufacturing best practices.

Skills and Abilities Required for This Job:

• Must adhere to the company code of conduct and contribute to fostering a professional, collaborative, and respectful team working environment.
• Highly self-disciplined and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.
• Expert in quality systems, risk management, and statistical techniques.  
• Must be able to work effectively and collaborate with cross functional teams as technical expert.
• Must be able to effectively articulate quality issues, investigation results, and conclusions, both verbally and in writing, to technical and non-technical personnel.
• Strong project management and documentation skills required.
• Must be able to take initiative and have the ability to perform hands-on work.
• Ability to manage multiple tasks with strong attention to detail.
• Strong presentation skills to represent Quality as a function during business meetings

Physical Requirements:

• Travel (~20%) may be required for audit support activities.
• Must be able to follow cleanroom, including compliance with applicable gowning and PPE requirements, and site safety protocols at all times.