Sr Quality Engineer, NPD/NPI
$105,000–$135,000 year
On-siteIrvine, California, United States
Job Summary
Lead quality engineering activities across new product development programs, ensuring compliance with regulatory requirements and industry standards throughout the product lifecycle. Author, review, and approve quality documentation including design control records, risk management files, and test protocols to support program milestones. Serve as the quality representative on cross-functional teams, providing guidance on design control and regulatory strategy from concept through commercial release. Identify and drive resolution of quality issues using structured problem-solving methodologies, while initiating and managing nonconformances, CAPAs, and engineering changes. Plan design verification and validation activities, support internal and external audits, and mentor junior engineers on design control processes. Collaborate with Regulatory Affairs, R&D, and Operations to integrate quality requirements into product design. Monitor product quality metrics, recommend corrective actions, and support post-market activities including complaint investigations. Requires 6–8+ years of experience in regulated medical device development, knowledge of FDA 21 CFR Part 820 and ISO standards, and 20–25% domestic and international travel.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related technical discipline, or equivalent combination of education and experience
- Minimum 6–8+ years of quality engineering experience within a regulated medical device or similarly regulated environment
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and quality system principles
- Demonstrated experience supporting new product development, design transfer, validation, and commercialization activities
- Proven experience authoring and managing design control documentation including DHF records, risk files, protocols, reports, and engineering documentation
- Experience with quality management systems (QMS), including CAPA, nonconformance management, change control, and document control processes
- Strong analytical, problem-solving, and root cause investigation skills
- Ability to manage multiple priorities independently in a fast-paced, cross-functional development environment
- Strong written and verbal communication skills, with the ability to effectively communicate technical and compliance information across all levels of the organization
- Ability to read, write, and communicate effectively in English
- Ability to interpret technical documents, engineering data, schematics, and written procedures
- Ability to clearly document technical findings and effectively communicate across cross-functional teams
- Must be able to move throughout office, laboratory, and light manufacturing environments as needed to support design reviews, product inspections, audits, and cross-functional collaboration
- Occasional lifting and carrying of materials or equipment up to 25 lbs
- Domestic and international travel up to 20–25%
Desired Qualifications
- Experience supporting Class II and/or Class III medical device development
- Experience with design transfer, manufacturing readiness, and NPI implementation activities
- Familiarity with FDA submission pathways, including 510(k), PMA, or De Novo
- Experience supporting FDA inspections, ISO audits, supplier audits, or Notified Body interactions
- Familiarity with IEC 60601, IEC 62366, ISO 80601 series, or other applicable product-specific standards
- ASQ Certified Quality Engineer (CQE) or equivalent professional certification
- Familiarity with Agile, phase-gate, or structured product development methodologies within a regulated environment
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