Lab and Med Device Director, Quality Management Manufacturing
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Castle Biosciences Inc. is growing, and we are looking to hire a Lab and Med Device Director, Quality Management Manufacturing working from our Phoenix, AZ office location, with a start date of May 31, 2026
Why Castle Biosciences?
Exceptional Benefits Package:
- Excellent Annual Salary + 35% Bonus Potential
- 20 Accrued PTO Days Annually + 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options + Company HSA Contribution
- Company Stock Grant Upon Hire
A DAY IN THE LIFE OF the Lab and Med Device Director, Quality Management Manufacturing
Castle Biosciences is seeking a Director of Quality Management to lead the development and execution of quality standards across laboratory, clinical, and manufacturing operations, with a primary focus on building scalable, inspection‑ready manufacturing and laboratory quality systems. This role owns the design and continuous improvement of an integrated QMS aligned with FDA, CLIA, CAP, and ISO requirements, partnering closely with manufacturing and laboratory operations leaders to embed quality across production, validation, and product lifecycle activities. This role will be integral to building out the new vertical within Castle's Laboratory and Device Manufacturing Operations.
REQUIREMENTS:
- Bachelor's degree in life sciences or engineering (e.g., Medical Technology, Biology, Chemistry, Biomedical Engineering).
- 10+ years in medical device quality, manufacturing, or product development; startup or early-stage experience a plus.
- 5+ years of demonstrated leadership or management in a regulated environment
- Strategic leadership in clinical and medical device regulatory compliance, with extensive expertise in FDA requirements and ISO standards (13485, 14971, 15189, 14155).
*Please see the full job description at the end of the job ad.
SCHEDULE
- Monday-Friday, salary exempt position, working onsite from our Phoenix, AZ location.
READY TO JOIN OUR BIOTECH TEAM?
We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!
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WORK AUTHORIZATION
All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.
ABOUT CASTLE BIOSCIENCES INC.
At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.
Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.
Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com.
This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
** No third-party recruiters, please