Senior Manager, Quality Engineering

The role

This leader will architect and direct quality engineering functions across the full product lifecycle of the Total Artificial Heart system. You will lead the quality engineering team in verification, validation, manufacturing process quality, supplier controls, and regulatory compliance.

What you will do

• Define and execute the strategic vision for the QMS
• Serve as the senior quality engineering authority for BSI surveillance audits and FDA inspections
• Lead and develop a high-performing quality engineering team
• Establish enterprise-wide quality KPIs
• Direct V&V planning, execution, and documentation for electrical, software, and system-level protocols
• Approve test protocols and reports
• Oversee test method validation and equipment qualification programs
• Architect and enforce IPC-A-610 workmanship standards
• Own the nonconformance and QCIR programs
• Lead FMEA, FTA, and risk management file strategy

Required qualifications

• Bachelor’s degree or higher in Electrical Engineering
• Minimum 18 years of experience in the medical device industry
• Demonstrated senior quality engineering leadership
• Direct experience with Class III Active Implantable Medical Devices (AIMD)
• Deep knowledge of FDA IDE/PMA regulatory requirements
• Expert knowledge of IEC 60601 series, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806
• Deep experience with electrical and electromechanical system qualification for implantable devices
• Proficiency in FMEA, FTA, statistical analysis, MSA/Gage R&R, and reliability methodology
• Experience with EO sterilization qualification, cleanroom operations, and QMS software platforms
• Proven track record of building and inspiring senior quality engineering teams
• Demonstrated ability to influence executive stakeholders and drive enterprise-level quality strategy
• Experience representing quality at a senior level in FDA or notified body inspections

Nice to have

• IPC-A-610 and/or IPC-A-620 certification
• VAD or Total Artificial Heart experience
• ASQ certification (CQE, CQM/OE, or CRE)
• Familiarity with Enlil, Arena, or comparable QMS/PLM platforms
• Experience with IDE clinical studies and associated quality system requirements

Benefits

• This position also qualifies for the benefits detailed at the link provided below

About the company

BiVACOR is developing the world's most advanced total artificial heart. The team is working on a technology capable of saving millions of lives.