Quality Assurance Lead Jobs in Massachusetts
Quality Assurance Lead jobs in Massachusetts are consistently active, concentrated in the state's robust life sciences, medical device, and defense manufacturing sectors, with demand at every level from associate QA lead through senior QA manager. The largest hiring markets are Boston, Marlborough, and Waltham, where employers such as Boston Scientific, Raytheon Technologies, and Biogen maintain major operations. Software quality and FDA-regulated manufacturing compliance are the most in-demand specialties across the state. Find a role that fits below and apply directly.
Find Quality Assurance Lead JobsOverview
Showing 5 of 66+ Quality Assurance Lead jobs
- Provide expertise in Risk Management, Design Verification and Validation, Process Validation, Statistical Methods and Design Controls.
- Drive Design Assurance activities throughout Product Life Cycle management.
- Drive quality system execution to U.S. regulations (21 CFR 820), International regulations and standards( IVDR and ISO 13485)
- Assist in maintaining and improving the quality management system documentation and processes to meet or exceed all applicable requirements
- Develop and validate test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
- Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
- Support supplier quality management, including maintaining the Approved Supplier List, performing audits of sub-contractors and material / component suppliers.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Execute and review engineering change orders and document change requests
- Facilitate product risk management activities (e.g., Risk Management Plans, Risk Management Reports, Risk Management Files, Hazard Analyses, FMEAs)
- Identify, prioritize, communicate and resolve quality issues given dynamic business needs
- Identify and implement effective process controls to support the development, qualification, and manufacturing of products.
- Generate quality metrics, perform trend analyses, and identify preventive / corrective actions to drive product quality and process improvements through the CAPA process or other methods.
- Participate in developing inspection requirements for procured and manufactured products.
- Lead MRB and Nonconformance activities
- Participate in internal and external audits and other quality system maintenance/improvement activities to be compliant with various regulatory standards and regulations, such as Management Review
- Provide support to the complaint handling function as required
- Provide support in design control activities as required.
- Perform other duties as assigned
- Bachelor of Science Degree in Engineering or Science
- At least 4 years’ experience in OEM medical device manufacturing of FDA approved or 510k cleared product
- Able to use Microsoft Office (Microsoft Word, Excel, PowerPoint)
- Extensive working knowledge of GMP, FDA regulations (21 CFR Part 820), ISO 13485
- Ability to write, review, and execute deviations, nonconformance reports, CAPAs, and complaints.
- Previous experience with electronic document management systems preferred
- Ability to read, understand and follow all company SOPs and guidelines.
- Utilize critical thinking skills to problem solve and troubleshoot.
- Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
- Good organizational skills and strong attention to detail.
- Must be able to perform job requirements independently with minimal supervision.
- Adjusts easily and readily to a fast-paced work environment with changing priorities
- Travel up to 5%
- Compensation: $120k to $140k with a 7% target bonus.
- Provide expertise in Risk Management, Design Verification and Validation, Process Validation, Statistical Methods and Design Controls.
- Drive Design Assurance activities throughout Product Life Cycle management.
- Drive quality system execution to U.S. regulations (21 CFR 820), International regulations and standards( IVDR and ISO 13485)
- Assist in maintaining and improving the quality management system documentation and processes to meet or exceed all applicable requirements
- Develop and validate test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
- Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
- Support supplier quality management, including maintaining the Approved Supplier List, performing audits of sub-contractors and material / component suppliers.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Execute and review engineering change orders and document change requests
- Facilitate product risk management activities (e.g., Risk Management Plans, Risk Management Reports, Risk Management Files, Hazard Analyses, FMEAs)
- Identify, prioritize, communicate and resolve quality issues given dynamic business needs
- Identify and implement effective process controls to support the development, qualification, and manufacturing of products.
- Generate quality metrics, perform trend analyses, and identify preventive / corrective actions to drive product quality and process improvements through the CAPA process or other methods.
- Participate in developing inspection requirements for procured and manufactured products.
- Lead MRB and Nonconformance activities
- Participate in internal and external audits and other quality system maintenance/improvement activities to be compliant with various regulatory standards and regulations, such as Management Review
- Provide support to the complaint handling function as required
- Provide support in design control activities as required.
- Perform other duties as assigned
- Bachelor of Science Degree in Engineering or Science
- At least 4 years’ experience in OEM medical device manufacturing of FDA approved or 510k cleared product
- Able to use Microsoft Office (Microsoft Word, Excel, PowerPoint)
- Extensive working knowledge of GMP, FDA regulations (21 CFR Part 820), ISO 13485
- Ability to write, review, and execute deviations, nonconformance reports, CAPAs, and complaints.
- Previous experience with electronic document management systems preferred
- Ability to read, understand and follow all company SOPs and guidelines.
- Utilize critical thinking skills to problem solve and troubleshoot.
- Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
- Good organizational skills and strong attention to detail.
- Must be able to perform job requirements independently with minimal supervision.
- Adjusts easily and readily to a fast-paced work environment with changing priorities
- Travel up to 5%
- Compensation: $120k to $140k with a 7% target bonus.
See All 66 Quality Assurance Lead Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Quality Assurance Lead JobsQuality Assurance Lead Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Quality Assurance Lead Job Market in Massachusetts
A snapshot from current Massachusetts openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Healthcare & Medical Services
- Biotechnology & Pharmaceuticals
- Technology & Software
- Consulting & Professional Services
- Medical Devices
What Massachusetts Employers Look For
The qualifications that appear most often in quality assurance lead jobs across Massachusetts.
- Bachelor's degree in engineering, life sciences, or a related technical field
- Three or more years of quality assurance experience in a regulated industry
- Working knowledge of FDA 21 CFR Part 820 or ISO 13485 quality standards
- Demonstrated experience leading audits, CAPAs, and non-conformance investigations
- Proficiency with quality management systems such as MasterControl or Veeva Vault
- ASQ Certified Quality Engineer or equivalent professional certification preferred
Quality Assurance Lead Jobs in Massachusetts: Frequently Asked Questions
How do you become a quality assurance lead in Massachusetts?
Most quality assurance lead roles in Massachusetts require a bachelor's degree in engineering, life sciences, or a related field combined with hands-on QA experience in a regulated environment. Massachusetts does not issue a state-specific QA license, but employers in the state's medical device and biotech sectors strongly favor candidates holding ASQ certifications such as the Certified Quality Engineer or Certified Quality Auditor. Building experience with FDA-regulated quality systems is the most reliable path to a lead-level role here.
How much do quality assurance leads make in Massachusetts?
Quality assurance leads in Massachusetts earn a median of about $122,210 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $68,050 for the lowest 10% to over $168,000 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire quality assurance leads in Massachusetts?
Employers hiring quality assurance leads in Massachusetts right now include Replimune, Redwire Space, and Boston Scientific, based on current listings on Migrate Mate as of August 2026. Massachusetts's dense concentration of medical device, biotech, and defense contractors means QA lead openings appear consistently throughout the year across both large corporations and mid-size contract manufacturers.
Which Massachusetts cities have the most quality assurance lead jobs?
The cities with the most quality assurance lead openings in Massachusetts are Boston, Marlborough, and Waltham. Boston anchors demand through its flagship biotech and hospital research campuses, while Marlborough and Waltham draw heavily on the Route 128 technology and medical device corridor, where major employers maintain large manufacturing and R&D facilities that generate ongoing QA lead hiring.
Are there remote quality assurance lead jobs in Massachusetts?
Yes, but they are less common than in purely desk-based fields because many QA lead roles require on-site presence for audits, equipment inspection, and production floor oversight. About 55% of quality assurance lead openings tied to Massachusetts are remote or hybrid as of August 2026, with remote work most available for roles focused on documentation, supplier quality management, and software or system validation rather than physical manufacturing.
How can I get hired as a quality assurance lead in Massachusetts with little or no experience?
The most realistic entry path is starting as a QA associate or QA technician at a Massachusetts medical device or biotech manufacturer, then building toward a lead role from within. Large employers across the Route 128 corridor, including contract manufacturers and mid-size life sciences companies, regularly hire for entry-level QA roles that do not require prior lead experience. Earning an ASQ Certified Quality Technician credential and gaining hands-on exposure to CAPA processes and ISO or FDA documentation standards significantly strengthens a candidate's profile for promotion.
Where can I find and apply to quality assurance lead jobs in Massachusetts?
You can find and apply to quality assurance lead jobs in Massachusetts on Migrate Mate, which lists current openings across the state. Search the available roles, find ones that fit your background and location, and apply directly to the ones that match.
See All 66 Quality Assurance Lead Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Quality Assurance Lead Jobs