Senior Site Quality Manager - Med Device

Insight Global; Chelmsford (MA); On-site; USD 160,000 - 175,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Senior Site Quality Manager to oversee quality assurance processes, manage audits, and ensure compliance with regulations. The role requires strong leadership and collaboration across functions to maintain high-quality standards. Ideal candidates will have experience in quality management and a solid understanding of FDA requirements.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Experience in quality management within medical device manufacturing.
• Strong knowledge of FDA regulations and quality standards.

Responsibilities

• Review and approve SOPs, work instructions, and quality policies.
• Plan and conduct internal audits and prepare for external audits.
• Oversee batch record reviews and ensure product quality.

Skills

Quality Management

Auditing

Lean Six Sigma

Job description

Senior Site Quality Manager - Med Device

Senior Site Quality Manager - Med Device

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This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$160,000.00/yr - $175,000.00/yr

Direct message the job poster from Insight Global

• Reviewing and approving Standard Operating Procedures (SOPs), work instructions, and quality policies.
• Ensuring controlled documents are current, accessible, and properly archived.
• Managing training records to ensure staff are trained on the latest procedures.

2. Internal Audits & Inspection Readiness

• Planning and conducting internal audits to identify gaps or nonconformances.
• Preparing for external audits (e.g., FDA, Notified Bodies, MDSAP).
• Leading audit response efforts, including CAPA (Corrective and Preventive Actions).

3. Product Quality Oversight

• Overseeing batch record reviews, product release, and final quality checks.
• Ensuring nonconforming product is properly identified, segregated, and dispositioned.
• Monitoring in-process controls and quality trends.
• Leading or reviewing CAPA investigations to address systemic issues.
• Participating in risk assessments (e.g., FMEA) for processes and products.
• Ensuring timely closure and effectiveness checks of CAPAs.
• Tracking quality KPIs (e.g., complaint rates, audit findings, CAPA cycle time).
• Leading quality improvement projects using Lean or Six Sigma tools.
• Reporting quality performance to site leadership and global QA.

6. Cross-Functional Collaboration

• Working with manufacturing, engineering, regulatory, and supply chain to ensure quality is built into every step.
• Supporting design transfer and change control processes.
• Participating in management reviews and strategic planning.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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