Quality Management System Lead

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

Message from the Hiring Manager:

Caldera 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 Neuchâtel — 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 company's 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.

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.

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.

15% travel required.

Competitive Compensation, Comprehensive Benefits, and more!

• $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!

( This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position. )

Our Culture- Where Career and Passion come together!

• A Culture of family and team… not a corporate goliath where you’re just another number.
• All 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.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Who is Caldera Medical?

Caldera 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 5000’s 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.

Caldera 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 veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.