Quality Control Manager

Reva Medical LLC • San Diego, CA

20h • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience with combination products (device + drug) is strongly preferred.
• Background in interventional cardiology products (drug-eluting stents, balloon catheters, scaffolds, etc.) is a plus.

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.

Benefits

• Opportunity to make a direct impact on groundbreaking cardiovascular technologies.
• Competitive compensation and benefits package.
• Collaborative, mission-driven culture in a growing company.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees