Quality Manager, Medical Device Manufacturing (ISO 13485, Hawthorne, CA)

Quality Manager, Medical Device Manufacturing (ISO 13485, Hawthorne, CA) at Pave Talent Quality Manager, Medical Device Manufacturing (ISO 13485, Hawthorne, CA) at Pave Talent in Redondo Beach, California Posted in 8 days ago.

Type:

full-time

Job Description:

If you've spent years keeping a QMS audit-ready while firefighting NCRs and chasing down overdue CAPAs, you already know the job. The question is whether the company you're doing it for actually values quality as a function or just treats it like a checkbox. This one takes it seriously. ? ???????????? ???????????????????????????? ? Pave Talent is hiring on behalf of our client, an established and growing medical device contract manufacturer in Hawthorne, CA specializing in tight-tolerance orthopedic implants, bone screws, cages, and surgical instruments.

ISO 13485

certified since 2014, with roots in precision machining going back decades. This is a vertically integrated facility running Swiss turning, CNC milling, gundrilling, CMM inspection, laser marking, and passivation all under one roof. The materials are exotic (titanium, stainless steel), the tolerances are unforgiving, and the quality standards reflect it. ? ???????????? ???????????????????????????????????????????? ? You'll own the entire quality function for a precision manufacturing operation that serves major orthopedic OEMs. This means leading inspection, metrology, document control, CAPA, supplier quality, and customer quality. You'll report to senior leadership, manage a team of Quality Inspectors, Document Control personnel, and Quality Engineers, and serve as the primary point of contact for customer audits and regulatory readiness. The company is in a growth phase with strong customer demand, which means your work will directly impact the trajectory of the business. ? ???????????????? ????????????'???????? ???????????? ?

• Maintain and improve the QMS in full compliance with

ISO 13485, FDA 21 CFR

820, and customer-specific requirements

• Lead internal audits, management reviews, and preparation for customer and regulatory audits
• Oversee incoming, in-process, and final inspection activities across the facility
• Manage calibration, gage control, and metrology equipment including CMMs, vision systems, and hand tools
• Drive root-cause investigations using 5-Why, Fishbone, DMAIC, and similar methodologies
• Own CAPA implementation, verification, and closure timelines
• Manage nonconformances, deviations, concessions, and customer notifications
• Serve as the primary contact for customer quality issues, audits, and source inspections
• Run supplier evaluations, audits, scorecards, and corrective actions
• Support FAIRs, PPAP, validation protocols, and risk management documentation
• Track and report KPIs including scrap, rework, yield, audit findings, customer complaints, and CAPA performance ? ???????????????????????????????????????????????????????? ? ????????????????????????????????:
• 5+ years of quality experience in medical device manufacturing, precision machining, or regulated production
• Strong working knowledge of

ISO 13485, FDA QSR

(21 CFR 820), and GD&T

• Experience leading audits, managing CAPA systems, and maintaining a compliant QMS
• Proficiency with metrology tools, CMMs, and inspection software
• Demonstrated leadership in a fast-paced manufacturing environment ? ???????????????????? ????????????????????????:
• Bachelor's degree in Engineering, Quality, or related field
• Experience in orthopedic or surgical implant manufacturing
• Background working with titanium and exotic alloys
• Familiarity with Global Shop ERP or similar manufacturing ERP systems
• ASQ CQM or CQE certification ?

???????????????????????????????????????????????? ???????????? ???????????????????????????????? ? ????????????????????????: Competitive, commensurate with experience (discuss on first call) ????????????????????????????????: 401(k) with 4% company match, health insurance, vision insurance, paid time off ????????????????????????????????: Full-time, on-site in Hawthorne, CA ???????????????????????? ????????????????????????????: Fast. Phone screen, face-to-face interview, and decision. No drawn-out assessment gauntlet. ? Interested? Apply via and we'll be in touch. Confidential search; your application is fully private. ? ???????????????? ???????????????????????? | ???????????????????????? ????????????????????????????????????????