Were seeking a dynamic and experienced Senior Quality Site Manager to lead quality operations at our Chelmsford facilitya 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, youll bring energy, vision, and technical expertise to elevate our quality culture and support ongoing transformation efforts. Youll lead a talented team through change, foster cross-functional collaboration, and ensure our products meet the highest standards of safety and performance.
Key Responsibilities
Leadership & Strategy
Lead and inspire a team of 34 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 sites 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.
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 the site.
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.
Travel: Up to 10%
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com. The EEOC "Know Your Rights" Poster is available
here.
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Bachelors 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.
Experience with both capital equipment and disposable medical devices.
Experience utilizing Agile, SAP, and Veeva Vault.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.