Quality Manager - Medical Device Manufacturing

Quality Manager - Medical Device Manufacturing EMPRO Staffing Hawthorne, CA Job Details Full-time $120,000 - $150,000 a year 8 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Qualifications Incident investigation techniques for hazard identification Measurement-based inspection Customer communication Defect resolution root cause analysis ISO standards Preventive action implementation Production deviation management Quality control preventive actions Corrective and preventive actions (CAPA) GD&T Manufacturing facility Managing engineering teams Medical device manufacturing facility experience Attention to detail Compliance documentation Leading team collaboration initiatives Internal compliance assessments Biomedical regulatory compliance Regulatory compliance analysis PPAP Hand tools Production process auditing Production documentation FDA regulations Audit support Failure analysis Full Job Description Lead Quality. Protect Compliance. Drive Precision. Are you a quality leader who takes pride in building strong systems, maintaining audit readiness, and holding teams accountable to high standards? We are looking for an experienced Quality Manager to lead quality operations for a high-precision medical device manufacturing environment. This role is responsible for maintaining a compliant, audit-ready

ISO 13485

Quality Management System while ensuring medical-grade components meet strict customer, regulatory, and quality requirements. Why Join Us? This is a leadership role where your work directly impacts compliance, customer confidence, production quality, and patient safety. Here's what you can expect: ✔ High-impact leadership opportunity ✔ Regulated medical device manufacturing environment ✔ Hands-on ownership of QMS, CAPA, audits, and inspection ✔ Opportunity to lead and develop a quality team ✔ Strong focus on precision, documentation, and continuous improvement ✔ A role where your decisions directly shape quality performance Key ResponsibilitiesQuality Management System Maintain and improve the QMS in compliance with

ISO 13485, FDA QSR / 21 CFR

820, and customer-specific requirements Ensure procedures, work instructions, forms, and records are controlled, current, and properly followed Lead internal audits, management reviews, and audit readiness activities Support customer and regulatory audits with strong documentation and preparation Inspection & Metrology Oversee incoming, in-process, and final inspection activities Manage calibration, gage control, and metrology equipment, including CMMs, vision systems, and hand tools Ensure proper use of GD&T, sampling plans, inspection methods, and quality documentation Support inspection accuracy and consistency across production

CAPA, NCR

& Root Cause Lead structured root-cause investigations using tools such as 5-Why, Fishbone, DMAIC, or similar methods Drive timely CAPA implementation, verification, and closure Manage nonconformances, deviations, concessions, and customer notifications Ensure corrective actions are effective, documented, and sustainable Customer & Supplier Quality Serve as the primary contact for customer quality issues, audits, and source inspections Manage supplier evaluations, audits, scorecards, and corrective actions Support customer documentation requirements, including FAIRs, PPAP, validation, and risk management Strengthen customer confidence through clear communication and disciplined follow-through Team Leadership Lead, coach, and develop Quality Inspectors, Document Control, and Quality Engineers Set clear expectations and hold team members accountable for performance and documentation accuracy Build a culture of quality, compliance, ownership, and continuous improvement Quality Metrics & Reporting Track and report KPIs including scrap, rework, yield, audit findings, customer complaints, and CAPA performance Present quality performance to leadership Use data to identify trends, reduce risk, and drive improvement initiatives What We're Looking For We are looking for someone who is: A strong quality leader with regulated manufacturing experience Detail-oriented and documentation-focused Comfortable leading audits and customer quality conversations Strong with root-cause analysis and corrective action discipline Confident managing teams, expectations, and performance Analytical, organized, and solutions-focused Able to drive accountability across the shop floor Committed to compliance, precision, and continuous improvement Qualifications / Requirements 5+ years of quality experience in medical device manufacturing, precision machining, or regulated production Strong knowledge of

ISO 13485, FDA QSR / 21 CFR

820, and GD&T Experience leading audits and maintaining a compliant QMS Experience managing CAPA, NCRs, root-cause investigations, and customer quality issues Proficiency with metrology tools, CMMs, inspection software, and quality documentation Demonstrated leadership ability in a fast-paced manufacturing environment Excellent communication, documentation, and problem-solving skills Bachelor's degree in Engineering, Quality, or a related field preferred Schedule & Physical Requirements Full-time opportunity in a medical device manufacturing environment Must be comfortable working in both office and production floor settings Regular interaction with inspection, production, engineering, customers, suppliers, and leadership Must be comfortable reviewing documentation, analyzing reports, and walking the production floor Ability to work in a fast-paced, compliance-driven manufacturing environment Why This Role Matters Quality leadership protects the customer, the company, and the end user. In medical device manufacturing, quality is not just paperwork. It is discipline, consistency, traceability, and trust. Your work helps ensure every component is built correctly, documented properly, and ready to meet customer and regulatory expectations. You are not just managing quality. You are building the system that keeps the operation compliant, accountable, and audit-ready. What Success Looks Like Audit-ready at all times with no surprises Strong documentation discipline across the shop Effective and timely CAPA closures with verified results Reduced scrap, rework, and customer escalations High customer confidence and strong supplier performance A well-trained, accountable, high-performing quality team Apply Today If you are an experienced quality leader who understands regulated manufacturing and takes pride in building strong, compliant systems, we would love to hear from you. Apply today and become part of a team that values quality, precision, accountability, and continuous improvement.

Equal Opportunity Employer:

We are committed to creating an inclusive workplace and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law.

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Pay:

$120,000.00 - $150,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off

Work Location:

In person