Quality Manager

We are seeking an experienced and hands‑on Quality Manager to lead and develop a dedicated quality team in a regulated medical device manufacturing environment. This is a clean‑room facility that performs its own in‑house sterilization processes.

This role offers the opportunity to make an immediate impact—guiding a capable but developing team to see the bigger picture, elevate standards, and ensure the highest level of compliance with stringent industry and regulatory requirements.

• Lead, mentor, and develop a team (including Quality Technicians, Chemists, Microbiologists, Document Control, and Customer Complaint staff).
• Foster a culture of quality awareness, continuous improvement, and accountability.
• Ensure compliance with applicable regulations and standards, including:
• ISO 13485 – Quality Management Systems for Medical Devices
• ISO 17665 – Sterilization of Health Care Products – Moist Heat
• ISO 11135 – Sterilization of Health Care Products – Ethylene Oxide
• ISO 11137 – Sterilization of Health Care Products – Radiation
• FDA 21 CFR requirements
• Serve as the facility’s designated representative for the drug program (U.S. citizenship required for this responsibility). Oversee and support sterilization procedures and validation activities.
• Lead or participate in internal and external audits, including FDA inspections and third‑party audits.
• Manage and improve QA/QC processes, document control systems, and customer complaint handling.
• Partner with production and engineering teams to resolve quality issues and drive preventive measures.
• Maintain readiness for audits and inspections at all times.
• Travel as needed to support international operations (~20%, primarily to Mexico).

• Bachelor’s degree in a relevant scientific, engineering, or quality discipline (or equivalent experience).
• 10+ years of progressive quality experience in medical device and/or pharmaceutical manufacturing
  .
• Proven success as a people manager
  , with the ability to bring out the best in diverse, technical teams.
• Strong working knowledge of FDA regulations and ISO standards relevant to medical devices and sterilization.
• Hands‑on leadership style—comfortable being present on the manufacturing floor, not just in an office.
• Experience in QA, QC, and Quality Management systems.
• Demonstrated success leading audits.
• U.S. citizenship (due to regulatory representative requirements).

• Experience in clean‑room manufacturing environments.

This is an opportunity to step into a leadership position where your expertise in regulated manufacturing and team leadership will directly shape product quality, compliance, and operational success. Joining an extremely collaborative environment with a great work culture in a fast‑paced and fun environment.