Site Quality Manager (Medical Device)

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

Job summary

A leading company is seeking a Senior Quality Assurance Manager in Chelmsford, MA, to lead quality operations for manufacturing medical devices. This role involves driving quality excellence, regulatory compliance, and mentoring a team of quality professionals. The ideal candidate will have extensive experience in quality leadership within the medical device industry and a strong grasp of quality methodologies. Join a dynamic team focused on continuous improvement and operational excellence.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Child care support

Disability insurance

Tuition assistance

Paid paternity leave

Qualifications

• 7+ years of leadership experience in quality or regulatory roles.
• Minimum of 4 years within the medical device industry.
• Strong understanding of quality tools and methodologies.

Responsibilities

• Lead and inspire a team of 3–4 direct reports and ~30 total quality professionals.
• Oversee end-to-end quality assurance activities.
• Ensure compliance with FDA and ISO standards.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Continuous Improvement

Interpersonal Skills

Education

Bachelor’s degree in engineering, science, or a related technical field

Tools

Agile

SAP

Veeva Vault

MasterControl

TrackWise

Job description

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

Senior Quality Assurance Manager – Chelmsford, MA

Schedule: Monday–Friday, 8:00 AM – 5:00 PM

Travel: Up to 10% (occasional travel to Ireland or sister sites in Mexico)

About the Role

We’re seeking a dynamic and experienced Senior Quality Site Manager to lead quality operations at our Chelmsford facility—a fast-paced site focused on manufacturing and packaging capital equipment and disposable medical devices. This role is critical to driving quality excellence, regulatory compliance, and continuous improvement across a team of 30+ quality professionals.

As a key member of the site leadership team, you’ll bring energy, vision, and technical expertise to elevate our quality culture and support ongoing transformation efforts. You’ll lead a talented team through change, foster cross-functional collaboration, and ensure our products meet the highest standards of safety and performance.

Key Responsibilities

• Lead and inspire a team of 3–4 direct reports and ~30 total quality professionals, including Quality Engineers, Quality Systems, and QC teams.
• Drive a culture of accountability, engagement, and continuous improvement across the site.
• Partner with operations, engineering, and leadership to support CAPA investigations, nonconformance reduction, and line-down resolution.
• Mentor and develop future quality leaders through coaching and structured growth opportunities.

Quality Operations

• Oversee end-to-end quality assurance activities, from incoming inspection to final release and distribution.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and other global regulatory standards.
• Maintain and improve the site’s Quality Management System (QMS), including documentation, training, calibration, and audit readiness.
• Support internal and external audits, field actions, and product recalls as needed.

Cross-Functional Collaboration

• Act as a quality advocate across the organization, aligning site-level goals with global quality objectives.
• Collaborate with sister sites and leverage enterprise resources to support capacity increases and quality initiatives.

What You Bring

Must-Haves

• Bachelor’s degree in engineering, science, or a related technical field (required).
• 7+ years of leadership experience in quality or regulatory roles. Minimum of 4 years within the medical device industry.
• Strong understanding of quality tools and methodologies (e.g., 5 Whys, Fishbone, CAPA).
• Proven ability to lead teams through change and drive performance in a regulated environment.
• High energy, strong interpersonal skills, and a collaborative leadership style.

Preferred Qualifications

• Experience with both capital equipment and disposable medical devices.
• Familiarity with Agile, SAP, and quality systems such as Veeva Vault, MasterControl, or TrackWise.

Why Join Us?

• Be part of a high-impact transformation at a growing site with increasing product volume and visibility.
• Work with a strong, capable team and help shape the future of quality at our company.
• Competitive compensation: $160,000–$175,000 base salary, 16% bonus, and long-term incentive eligibility.
• Opportunity to make a tangible difference in patient outcomes and operational excellence.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Insight Global by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Child care support

Disability insurance

Tuition assistance

Paid paternity leave

Get notified when a new job is posted.

Sign in to set job alerts for “Quality Assurance Manager” roles.

Methuen, MA $120,000.00-$140,000.00 1 day ago

Lexington, MA $120,000.00-$140,000.00 2 months ago

Food Safety and Quality Assurance Supervisor

Marlborough, MA $130,000.00-$155,000.00 3 days ago

Nashua, NH $146,670.00-$249,330.00 2 weeks ago

Sr. Quality Assurance Manager - Manufacturing/Med Device

Senior Manager / Associate Director, Clinical Quality Assurance (no agencies please)

Quality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)

Manager, Food Safety and Quality Assurance

Quality Manager for High Complexity CLIA Lab

Supervisor, Quality Assurance and Control, Gas Operations

Senior Manager, Quality Assurance Contamination Control and Sterility Assurance (Hybrid)

Quality Control Manager - Scheduler/Coordinator

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.