Description:
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.
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.
- 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.
Requirements:
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Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
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7+ years of experience in quality control, quality engineering, manufacturing quality, or a related medical device environment.
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Experience working within FDA-regulated medical device manufacturing and a strong understanding of 21 CFR Part 820 and ISO 13485.
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Experience leading investigations, non-conformances, CAPA, and root-cause analysis.
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Experience managing, mentoring, and developing quality professionals.
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Strong understanding of inspection, testing, process controls, and quality systems within a manufacturing environment.
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Ability to work effectively in a hands-on, fast-paced environment and manage multiple priorities.
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Experience with Class III medical devices, particularly implantable or structural heart products.
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Experience with tissue processing, tissue sewing, valve assembly, or other highly specialized medical device manufacturing processes.
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Experience supporting pivotal clinical trials and/or commercialization activities.
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Familiarity with MDSAP, CE Mark, and Health Canada regulatory requirements.
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Experience working in cleanroom environments and with environmental monitoring or bioburden testing.
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Strong leadership and team development skills with the ability to balance hands-on problem solving with strategic thinking.
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Excellent communication and collaboration skills with the ability to influence across functions.
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Demonstrated ability to thrive in an entrepreneurial environment where priorities can evolve and individuals are expected to roll up their sleeves and get things done.
We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well-being, and financial future.Our benefits package includes:
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Medical
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Dental
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Vision
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Flexible Spending Account (FSA)
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Basic Life
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401(k) Retirement Plan
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Paid Holidays
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PTO
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Maternity/Paternity paid leave
It is 4C Medical’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws.
