Director of Quality

ONSITE in Westlake Village, CA

Message from the Hiring Manager:

We are seeking a strategic and hands-on Director of Quality to lead the Quality organization across multiple facets of the business including Product Development, Manufacturing, Supplier Quality, and Post-Market activities. This leader will take full ownership of the Quality Management System (QMS), ensuring alignment with global medical device regulations such as ISO 13485, while leading reporting efforts and managing a high-performing, multi-site team.

Duties and Responsibilities:

- Lead and manage the end-to-end Quality function including R&D, manufacturing, supplier quality, distribution, and commercial support.

- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP, and other international regulations.

- Own and continuously improve the Quality Management System (QMS), driving standardization across global operations.

- Direct and develop quality strategies for new product development (NPD), including design control, risk management, reliability engineering, and validation.

- Manage Quality oversight for multi-site manufacturing and contract manufacturers.

- Oversee CAPA, nonconformance, deviation investigations, complaint handling, and trend analysis.

- Represent Quality in audits and inspections (FDA, Notified Body, internal), and lead preparation and remediation activities.

- Lead cross-functional collaboration with R&D, Regulatory, Clinical, Manufacturing, Supply Chain, Finance, and Commercial teams.

- Guide and mentor quality engineering and quality assurance teams; manage team performance, development, and departmental budget.

- Support due diligence and integration for M&A activities, aligning acquired businesses to the corporate QMS.

- Champion a strong culture of quality and compliance while enabling business growth and operational efficiency.

Required Knowledge, Skills and Abilities:

- Bachelor’s degree in engineering, Life Sciences, or a related technical field.

- 10+ years of experience in medical device Quality, including leadership roles.

- Minimum of 5 years managing direct reports, including cross-functional or cross-site teams.

- Proven experience owning and leading a QMS in a regulated medical device environment.

- Demonstrated experience leading and remediating audits by regulatory bodies.

- Ability to lead changes, implement process improvements, and drive cultural transformation.

- Collaboration with quality, manufacturing, R&D, supply chain.

Travel

- Up to 25% travel may be required for supplier visits, audits or manufacturing sites.

Competitive Compensation, Comprehensive Benefits, and more!

• $150K-$170K Annual Salary
• Medical and Dental Benefits – 75% paid 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- including your birthday!
• Being surrounded by amazing people!

(This role is being filled internally, and we are not engaging external agencies at this time.)

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.