Principal Engineer I, Quality Systems

Jenavalve Technology Inc; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Jenavalve Technology Inc in Irvine, CA seeks a Principal Engineer, Quality Systems to lead CAPA, NCRs, change control, audits, and QMS improvements for medical devices under FDA 21 CFR 820 and ISO 13485. You will collaborate across Regulatory, Manufacturing Operations and R&D to embed quality into the product lifecycle.

The role requires 10+ years in medical device quality with a BS in Biomedical Engineering; MS preferred.

Qualifications

• Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
• Background in quality system elements across product lifecycle.
• Proven ability to lead audits and CAPA programs.
• Strong analytical and problem-solving skills.

Responsibilities

• Collaborate with Regulatory, Manufacturing Ops, and R&D to support QMS and core processes.
• Lead CAPA, NCRs, MRB, internal audits, and management reviews.
• Plan and execute supplier audits and inspection readiness activities.
• Support FDA inspections and Notified Body audits.
• Evaluate and validate modern analytical tools and quality metrics.
• Harmonize quality KPIs across sites globally.
• Provide technical guidance to quality specialists and junior engineers.
• Ensure traceability and documentation across QMS records.

Skills

Quality Systems

Quality Engineering

Regulatory knowledge

CAPA

Audit experience

Cross-functional collaboration

Statistical techniques

Documentation skills

Project management

Problem solving

Education

Bachelor of Science in Biomedical Engineering

Master of Science preferred

Job description

Job Title: Principal Engineer, Quality SystemsPrincipal Engineer I, Quality SystemsPrincipal Engineer II, Quality SystemsPrincipal Engineer III, Quality SystemsRole Level: Individual ContributorSupervisor/Manager Title: Director, Global Quality and ComplianceJob Location & Environment: Irvine, CA – Corporate OfficeJob 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 globallySupport 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 initiativesProvide 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 14971Knowledge 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 meetingsPhysical 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.