Quality Control Manager

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a Class III structural heart device through pivotal clinical trials, with a shared focus on delivering a high-quality product that can make a meaningful difference for patients.

At 4C Medical, you’ll find an environment where your ideas matter, your growth is prioritized, and your contributions directly influence our success. We’re committed to fostering both personal and professional development in a culture built on accountability, curiosity, and shared purpose.

THE OPPORTUNITY

We are seeking a Quality Control Manager to lead day-to-day QC operations for our highly specialized medical device manufacturing environment. This is a hands-on leadership opportunity where you will oversee inspection, testing, compliance, and quality activities across complex processes including tissue processing, valve assembly, Nitinol frame shape-setting, delivery system fabrication, and cleanroom packaging.

You will lead a team of five quality engineering and inspection professionals while helping ensure the organization remains audit-ready as we progress toward commercial approvals in the U.S., Europe, and Canada.

HOW YOU WILL CONTRIBUTE

· QC Operations & Assembly Support: Oversee daily inspection, testing, and release operations for raw materials, in-process components, and finished sterile devices. Drive rigorous quality oversight for the high-precision tissue-to-frame sewing and valve assembly processes.

· Audit Readiness & Compliance: Maintain a continuous state of audit readiness across the QC footprint. Ensure documentation, traceabilities, and processing environments comply with FDA, CE Mark, and Health Canada regulations.

· Non-Conformance & CAPA Management: Own the investigation, root-cause analysis, and disposition of non-conformances (NCMRs) and deviations. Directly handle failures or anomalies identified during complex valve assembly and sewing operations.

· Team Leadership & Development: Directly manage, mentor, and resource-load the QC team. Partner with the Quality Training Coordinator to ensure the highly specialized training and qualification matrices required for valve sewing and assembly are meticulously maintained.

· Process & Environmental Control: Oversee environmental monitoring, bioburden testing, and cleanroom compliance for the in-house tissue fixation, processing, and device assembly lines.

· Supplier Quality Oversight: Support the Sr. Supplier Quality Engineer in managing critical component vendors, resolving supplier corrective actions (SCARs), and coordinating incoming inspection criteria.