Director of Quality

Director of Quality / Snr / VP

Bay Area, CA | Full-Time Position | On Site Role

Medical Devices

Competitive Salary, Benefits & Stock

The Company

Join a cutting-edge medical device organization dedicated to transforming patient care. With a focus on innovation and life-saving solutions this company operates in a fast-paced startup environment, the team embraces challenges with enthusiasm and a commitment to delivering top-quality medical devices that make a real difference in patient outcomes.

The Opportunity

We are searching for a Director of Quality to lead and shape the quality functions. This high-impact role is ideal for a skilled professional who excels in problem-solving, navigating complex challenges, and driving operational excellence.

This is a senior leadership position whilst being very much a hands-on role.

This is your chance to contribute to a growing organization while leading quality initiatives that ensure compliance, improve processes, and foster innovation in a highly regulated industry.

An exciting time to join a thriving and growing start-up, with excellent financial backing and runway, heading towards big things in the next 2 years!

What You'll Do

• Lead strategic quality projects, including implementing electronic quality management systems (eQMS), achieving ISO 13485 certification, and ensuring product compliance with global regulations.
• Manage all quality functions, including sterilization and biocompatibility testing
• Act as a key representative during regulatory inspections and audits, ensuring alignment with FDA, EU MDR, and MDSAP standards.
• Provide mentorship and leadership to quality team (8-10 people), cultivating a culture of compliance and excellence.

What You Need to Succeed

Education & Experience:

• Bachelor’s degree in biological sciences, engineering, or a related field and 10+ years of experience in quality / regulatory role within the medical devices.
• 10+ years of experience managing and mentoring quality teams.
• Experience in vascular, cardio, neuro or catheter fields in MedTech

Key Skills:

• Deep knowledge of quality system regulations (ISO 13485, EU MDR, MDSAP).
• Proven experience with CAPA processes, sterilization standards, and statistical analysis tools (e.g., Six Sigma), Complaint Handling, Non-conformance, and Management Review.
• Exceptional leadership, communication, and problem-solving abilities.
• Strong project management skills with a track record of implementing scalable quality system improvements.

Why Join?

This is an opportunity to work at the forefront of medical innovation, leading impactful projects and being a key player in a product-focussed and high-growth environment

Apply now for a call back week commencing 9th December!