Senior Quality Engineering Manager – Medical Devices

OrthAlign, Inc.; Irvine (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation including a 0

Bonus and equity

Full benefits package

Career advancement opportunities

Top Place to Work in Orange County

Job summary

OrthAlign, Inc. in Irvine, California is seeking an Associate Manager, Quality Engineering to lead supplier quality programs for manufacturing, packaging, and related operations, ensuring compliance with ISO 13485 and regulatory requirements.

You will partner with design engineering and cross-functional teams to qualify suppliers, manage CAPA investigations, drive process transfers, and ensure readiness for full-scale production at contract manufacturers.

Qualifications

• BA/BS engineering degree with 5+ years in medical device supplier controls, or 4+ years in supplier controls.
• ASQ Certified Quality Engineer preferred.
• Auditing experience required, preferably supplier audits.
• Understanding of ISO 13485, ISO 14971, and 21 CFR Part 820 (design/purchasing controls, risk).
• Proficient leading CAPA investigations and supplier corrective actions.

Responsibilities

• Serve as the quality point of contact for parts, services and contract manufacturers.
• Lead supplier and CM qualification, onboarding with Manufacturing Eng and Supply Chain.
• Monitor supplier/CM performance via evaluations and audits.
• Collaborate with Design Quality Engineers on DFM/DFA and inspection requirements.
• Support development, validation (IQ/OQ/PQ), and transfer of processes and methods.
• Ensure readiness for full-scale production launches at CM.
• Lead quality ops for internal manufacturing processes.
• Create and maintain manufacturing documentation (MPs, Routers, MVPs, PFMEAs, BOMs, procedures).
• Lead CAPA investigations; support audits of QMS; drive improvements.
• Hire and develop direct reports; provide coaching and training opportunities.

Skills

Quality systems

CAPA investigations

Auditing

Supplier management

Communication

Team leadership

MS Office

Education

BA/BS Engineering-oriented degree

ASQ Certified Quality Engineer

Tools

MS Office Suite

Job description

OrthAlign, Inc. in Irvine, California is seeking an Associate Manager, Quality Engineering to lead supplier quality programs for manufacturing, packaging, and related operations, ensuring compliance with ISO 13485 and regulatory requirements.

You will partner with design engineering and cross-functional teams to qualify suppliers, manage CAPA investigations, drive process transfers, and ensure readiness for full-scale production at contract manufacturers.