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Senior Manufacturing Quality Manager – Medical Devices
Job in
Littleton, Middlesex County, Massachusetts, 01460, USA
Listed on 2026-08-14
Listing for:
Confidential Recruiting Partners
Full Time
position Listed on 2026-08-14
Job specializations:
-
Quality Assurance - QA/QC
Production QC/QA, Regulatory Compliance Specialist, Quality Engineering, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
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
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Provide leadership with data‑driven reporting on quality, performance and risk. - NCR/MRB Ownership
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Lead investigation, disposition, trending, and timely closure of nonconformances. - CAPA & Root Cause
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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
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Oversee in‑process inspection, final inspection, product acceptance, and release. - Team Management
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Manage Quality Engineers, the QC Supervisor, and inspection teams; coach and develop staff. - Continuous Improvement
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Apply Lean, Six Sigma, and risk‑reduction methodologies to improve yield and efficiency. - Quality Systems & Compliance
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Ensure compliance with ISO 13485, FDA QMSR, and other applicable regulations. - Cross‑Functional Collaboration
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Partner with Manufacturing, Engineering, Supply Chain, and Operations to resolve issues.
- 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)
- Life Insurance
- 10% annual target bonus
- Medical, Dental, and Vision
- 401(k) with company match
- Comprehensive paid leave
- Flexible working environment
Position Requirements
10+ Years
work experience
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