Quality Control Manager

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

• Bachelors degree in Chemistry Biology Engineering or a related scientific discipline (Masters preferred).
• 710 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 Skills & Attributes

• 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 wed love to hear from you.

Required Experience:

Manager