What are the responsibilities and job description for the Quality Control Manager position at REVA Medical, LLC?
Manager, Quality Control
REVA Medical – San Diego, CA Full-Time | On-site
REVA Medical is pioneering next-generation bioresorbable vascular scaffolds and combination products to transform the treatment of coronary artery disease. We are seeking a hands-on Manager, Quality Control to lead our QC laboratory operations and play a critical role in ensuring the quality and timely release of our innovative medical devices.
About the Role
As the Manager, Quality Control, you will lead day-to-day QC laboratory operations supporting both development and commercial manufacturing. This is a leadership role that combines technical expertise, process development, and team management in a fast-paced startup environment.
Key Responsibilities
- Lead all QC laboratory activities, including analytical and mechanical testing of raw materials, in-process, and finished combination products.
- Ensure timely and accurate testing to support batch release and product disposition.
- Review and approve test records, documentation, and partner with QA for final lot release decisions.
- Build and optimize scalable QC processes, including sample management, SOPs, testing schedules, and lab systems.
- Transfer and implement new test methods from R&D, including method validation.
- Monitor and trend QC data to drive product and process improvements.
- Lead investigations for nonconformances and ensure timely resolution.
- Hire, train, develop, and lead a high-performing QC team in a collaborative, high-accountability culture.
- Maintain inspection readiness and actively support FDA and other regulatory audits.
Qualifications
- Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline (Master's preferred).
- 7–10 years of Quality Control experience in medical device, pharmaceutical, or combination product environments.
- Prior experience leading or managing a QC team in a GMP-regulated setting.
- Strong hands-on experience with analytical and mechanical testing methods.
- Proven track record supporting FDA inspections and maintaining cGMP compliance.
- Experience with combination products (device drug) is strongly preferred.
- Background in interventional cardiology products (drug-eluting stents, balloon catheters, scaffolds, etc.) is a plus.
Key SkillsAttributes
- Strong leadership and people management skills.
- Excellent organizational, planning, and process improvement abilities.
- Skilled in SOP development, root cause analysis, and cross-functional collaboration.
- Comfortable operating in a fast-paced, evolving startup environment.
What We Offer
- Opportunity to make a direct impact on groundbreaking cardiovascular technologies.
- Competitive compensation and benefits package.
- Collaborative, mission-driven culture in a growing company.
If you are a detail-oriented leader who thrives in building scalable QC systems and wants to contribute to life-changing medical innovation, we'd love to hear from you.