Senior Manufacturing Quality Manager - Medical Devices

Our client is seeking an experienced Senior Quality Manager to own manufacturing quality performance, including inspection activities, NCR/MRB processes, CAPA, and quality systems execution. This role is highly visible within operations and requires strong leadership, cross‑functional collaboration, and hands‑on shop‑floor engagement.

Onsite | No Visa Sponsorship | No Relocation Assistance

Responsibilities:

• Audit Support: Support internal/external audits, including regulatory inspections.
• Supplier Quality: Support incoming material quality and vendor‑related troubleshooting.
• Quality Reporting: Provide leadership with data‑driven reporting on quality, performance and risk.
• NCR/MRB Ownership: Lead investigation, disposition, trending, and timely closure of nonconformances.
• CAPA & Root Cause: Drive corrective actions based on manufacturing trends and structured root‑cause analysis.
• Manufacturing Quality Leadership: Lead all manufacturing‑related quality activities across production operations.
• Inspection & Product Release: Oversee in‑process inspection, final inspection, product acceptance, and release.
• Team Management: Manage Quality Engineers, the QC Supervisor, and inspection teams; coach and develop staff.
• Continuous Improvement: Apply Lean, Six Sigma, and risk‑reduction methodologies to improve yield and efficiency.
• Quality Systems & Compliance: Ensure compliance with ISO 13485, FDA QMSR, and other applicable regulations.
• Cross‑Functional Collaboration: Partner with Manufacturing, Engineering, Supply Chain, and Operations to resolve issues.

Qualifications (Must-Haves)

• 3+ years managing Quality Engineers and/or QC teams.
• Ability to travel 5–10% for vendor support, customer visits, and system testing.
• Bachelor's degree in Engineering (Mechanical, Electrical, or related) or equivalent experience.
• Strong knowledge of ISO 13485, risk‑based quality principles, and regulated QMS requirements.
• Hands‑on ownership of manufacturing quality, including NCR/MRB, CAPA, and shop‑floor execution.
• 8+ years of progressive Quality experience in regulated manufacturing (medical device required; aerospace/defense/IVD acceptable with relevant crossover)

Benefits & Perks:

• Life Insurance
• 10% annual target bonus
• Medical, Dental, and Vision
• 401(k) with company match
• Comprehensive paid leave
• Flexible working environment