Quality Management System Leader

divh2Caldera Medical Quality Management System Architect/h2pLocated in Westlake Village, CA; Onsite - No remote option. Caldera Medicals Mission - To Improve the Quality of Life for Women!/ppMessage from the Hiring Manager:/ppCaldera Medical requires a senior quality leader to serve as both the on-site Quality Lead for the Westlake manufacturing facility and the enterprise-wide architect and steward of the Quality Management System. As the company grows across multiple sites including operations in Neuchtel maintaining a robust, harmonized QMS that meets ISO 13485, FDA QSR/QMSR, and EU MDR requirements is essential to regulatory standing, product quality, and market access. This role is critical to sustaining audit readiness, driving a culture of continuous improvement, and protecting the companys ability to scale into new markets and sites. Reporting to the Head of Quality, this individual will lead the site QA/QC team, own the corporate QMS, and serve as the primary interface with regulators and notified bodies./ppDuties and Responsibilities:/ppSite Quality Leadership:/pp Serve as overall Quality lead for the Westlake site; own day-to-day quality operations and long-term quality strategy./pp Lead, coach, and develop the site quality team (QA Operations, Quality Engineers, QC/Lab, Document Control, Complaints)./pp Oversee manufacturing quality controls: incoming inspection, final product release, nonconformance management, and change control./pp Establish and monitor site KPIs (defects, scrap, deviations, complaints, CAPA timeliness); drive continuous improvement./pp Authority to initiate temporary production holds or shipment holds and escalate to Head of Quality./ppQMS Ownership:/pp Act as global process owner for the QMS across all Caldera Medical sites./pp Own and continuously improve the Quality Manual, corporate quality policy, and all core quality procedures./pp Ensure all procedures meet ISO 13485, FDA 21 CFR 820/QMSR, and EU MDR requirements./pp Lead the internal audit program across all sites; manage notified body, MDSAP, and FDA inspection readiness./pp Chair or co-chair the CAPA review board and corporate management review meetings./pp Champion a risk-based, data-driven approach to QMS changes and preventive actions organization-wide./ppRequired Knowledge, Skills and Abilities:/ppBachelors degree in Engineering, Life Sciences, Quality Management, or related field./ppMinimum 1015 years of progressive Quality experience in a regulated industry (medical devices preferred; pharma or biotech considered)./ppMinimum 5 years of direct QMS ownership or leadership (QMS Manager, Quality Systems Lead, or Quality Manager with primary QMS responsibility)./ppProven experience designing and maintaining ISO 13485 and ISO 9001 quality management systems in multi-site organizations./ppDemonstrated success leading internal and external audits (ISO 13485, MDSAP, FDA QSR, notified body) and managing audit responses./ppExperience 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./ppFrench language skills./pp15% travel required. Competitive Compensation, Comprehensive Benefits, and more!/pulli$130,000-150,000 Annual Salary/liliMedical and Dental Benefits for employee and family members/liliVision Coverage/lili401(k) with 4% matching contributions after 90 days of employment/liliBasic Life and ADD/liliUnlimited Vacation Policy/lili6 Weeks Paid Maternity Leave/lili10 paid holidays/liliBeing surrounded by amazing people!/li/ulpOur Culture- Where Career and Passion come together!/pulliA Culture of family and team not a corporate goliath where youre just another number./liliAll employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California./liliThe Womens Health Initiative is the heart of what we do, every day we put underprivileged women first./liliOur goal is to treat 1 million women suffering from incontinence by 2027!/li/ulpWho is Caldera Medical?/ppCaldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide./ppCaldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veterans status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law./p/div