Quality Management System Leader

Role Overview Located in Westlake Village, CA; Onsite – no remote option. Caldera Medical’s Mission: Improve the Quality of Life for Women. Message from the Hiring Manager: Caldera Medical requires a senior quality leader to serve as the on-site Quality Lead for the Westlake manufacturing facility and the enterprise‑wide architect and steward of the Quality Management System. The role reports to the Head of Quality and is responsible for maintaining a robust QMS that meets ISO 13485, FDA QSR/QMSR, and EU MDR requirements across multiple sites. Duties and Responsibilities Site Quality Leadership: Serve as overall Quality lead for the Westlake site; own day‑to‑day quality operations and long‑term quality strategy. Lead, coach, and develop the site quality team (QA Operations, Quality Engineers, QC/Lab, Document Control, Complaints). Oversee manufacturing quality controls: incoming inspection, final product release, nonconformance management, and change control. Establish and monitor site KPIs (defects, scrap, deviations, complaints, CAPA timeliness); drive continuous improvement. Authority to initiate temporary production holds or shipment holds and escalate to Head of Quality. QMS Ownership: Act as global process owner for the QMS across all Caldera Medical sites. Own and continuously improve the Quality Manual, corporate quality policy, and all core quality procedures. Ensure all procedures meet ISO 13485, FDA 21 CFR 820/QMSR, and EU MDR requirements. Lead the internal audit program across all sites; manage notified body, MDSAP, and FDA inspection readiness. Chair or co‑chair the CAPA review board and corporate management review meetings. Champion a risk‑based, data‑driven approach to QMS changes and preventive actions organization‑wide. Travel 15% travel required. Required Knowledge, Skills and Abilities Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related field. Minimum 10–15 years of progressive Quality experience in a regulated industry (medical devices preferred; pharma or biotech considered). Minimum 5 years of direct QMS ownership or leadership (QMS Manager, Quality Systems Lead, or Quality Manager with primary QMS responsibility). Proven experience designing and maintaining ISO 13485 and ISO 9001 quality management systems in multi‑site organizations. Demonstrated success leading internal and external audits (ISO 13485, MDSAP, FDA QSR, notified body) and managing audit responses. Experience with eQMS or document management systems preferred. Desired certifications: CQA or CQE (ASQ); Lead Auditor ISO 13485/9001; Six Sigma Black Belt or Lean a plus. French language skills. Competitive Compensation and Benefits $130,000‑150,000 Annual Salary Medical and Dental Benefits – for employee and family members Vision Coverage 401(k) with 4% matching contributions after 90 days of employment Basic Life and AD&D Unlimited Vacation Policy 6 Weeks Paid Maternity Leave 10 paid holidays Being surrounded by amazing people! Caldera Medical is an equal opportunity employer and considers all applicants for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law. #J-18808-Ljbffr