Quality Assurance Engineer Jobs in Massachusetts
Quality Assurance Engineer jobs in Massachusetts are concentrated in the life sciences, defense, and medical device sectors, with consistent demand at every level from entry-level test associates through senior QA leads. Boston, Cambridge, and Marlborough are the primary hiring hubs, anchored by employers such as Raytheon Technologies, Boston Scientific, and Biogen, which maintain large quality and regulatory operations in the state. The most in-demand specialties include software QA automation, FDA-regulated manufacturing quality, and systems validation for medical and aerospace applications. Find a role that fits below and apply directly.
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Showing 5 of 117+ Quality Assurance Engineer jobs
Title: Sr. Associate Manufacturing Quality Assurance
Job Summary
Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products. Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US FDA cGMP, QSR, ISO and other applicable international regulations and guidance documents.
Risk Management aspects including Quality Alerts, Field Alert Reporting, Product Complaints, Recall, and Site Quality Management Review content. In addition, development of Quality Standards for functions managed within Quality Compliance, and driving overall GxP strategic direction for these quality activities, programs and objectives.
Area Of Responsibility
- Perform in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process
- Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits. Facilitate review and support regulatory inspection management.
- Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
- Collaborate with Corporate compliance group and implement global CAPA.
- Support for major health authority inspections at site and provide input and support to inspection readiness/ responses to drive consistency and clarity at the site. Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
- Support compliance investigations as needed, in collaboration with others at the site.
- Perform complaint investigations through analyzing returns and reviewing batch records, and provide written reports of findings
- Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system
- Interface extensively on a daily basis with all departments.
- Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business
- Other duties as assigned.
Work Conditions:
Corporate Office Environment
Manufacturing / Production Environment
Laboratories
Warehouse Environment
Field Familiarity Environment
Physical Requirements:
- Must be capable of bending and lifting, moving and/or carrying up to approximately 50 pounds.
- Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.
- Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Travel Estimate
Up to 5%
Education and Job Qualification
- High School Diploma required, Bachelor’s degree in life sciences preferred.
- Must have a thorough knowledge of quality system requirements.
- Demonstrated excellent communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- A team building champion driving innovative cross functional synergies.
- Excellent project management and problem solving skills.
- Strong mathematical skills.
- Demonstrated proficiency with Microsoft Word, Microsoft Excel, and Microsoft Outlook programs.
Experience
- Minimum of eight (8) years of experience in the FDA regulated medical device or pharmaceutical industry.
- Experience with Trackwise, EDMS, and Mastercontrol preferred.
- Must have experience with cGMP, QSR and ISO regulations.
- Must have experience performing inspections and investigations.
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
The presently-anticipated base compensation pay range for this position is $111,000 to $135,000.Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Title: Sr. Associate Manufacturing Quality Assurance
Job Summary
Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products. Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US FDA cGMP, QSR, ISO and other applicable international regulations and guidance documents.
Risk Management aspects including Quality Alerts, Field Alert Reporting, Product Complaints, Recall, and Site Quality Management Review content. In addition, development of Quality Standards for functions managed within Quality Compliance, and driving overall GxP strategic direction for these quality activities, programs and objectives.
Area Of Responsibility
- Perform in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process
- Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits. Facilitate review and support regulatory inspection management.
- Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
- Collaborate with Corporate compliance group and implement global CAPA.
- Support for major health authority inspections at site and provide input and support to inspection readiness/ responses to drive consistency and clarity at the site. Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.
- Support compliance investigations as needed, in collaboration with others at the site.
- Perform complaint investigations through analyzing returns and reviewing batch records, and provide written reports of findings
- Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system
- Interface extensively on a daily basis with all departments.
- Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business
- Other duties as assigned.
Work Conditions:
Corporate Office Environment
Manufacturing / Production Environment
Laboratories
Warehouse Environment
Field Familiarity Environment
Physical Requirements:
- Must be capable of bending and lifting, moving and/or carrying up to approximately 50 pounds.
- Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.
- Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Travel Estimate
Up to 5%
Education and Job Qualification
- High School Diploma required, Bachelor’s degree in life sciences preferred.
- Must have a thorough knowledge of quality system requirements.
- Demonstrated excellent communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- A team building champion driving innovative cross functional synergies.
- Excellent project management and problem solving skills.
- Strong mathematical skills.
- Demonstrated proficiency with Microsoft Word, Microsoft Excel, and Microsoft Outlook programs.
Experience
- Minimum of eight (8) years of experience in the FDA regulated medical device or pharmaceutical industry.
- Experience with Trackwise, EDMS, and Mastercontrol preferred.
- Must have experience with cGMP, QSR and ISO regulations.
- Must have experience performing inspections and investigations.
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
The presently-anticipated base compensation pay range for this position is $111,000 to $135,000.Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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Find JobsQuality Assurance Engineer Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Quality Assurance Engineer 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
- Consulting & Professional Services
- Medical Devices
- Construction & Real Estate
What Massachusetts Employers Look For
The qualifications that appear most often in quality assurance engineer jobs across Massachusetts.
- Bachelor's degree in engineering, computer science, or a related technical discipline
- Experience with test planning, test case design, and defect tracking tools
- Proficiency in automated testing frameworks such as Selenium, pytest, or equivalent
- Familiarity with FDA quality system regulations or ISO 9001 standards
- Strong understanding of SDLC and agile development methodologies
- Experience with requirements traceability and validation documentation practices
Quality Assurance Engineer Jobs in Massachusetts: Frequently Asked Questions
How do you become a quality assurance engineer in Massachusetts?
Most employers in Massachusetts require a bachelor's degree in engineering, computer science, or a closely related field, though candidates from adjacent disciplines are frequently considered. There is no state-issued license specific to quality assurance engineering in Massachusetts, but certifications such as the ASQ Certified Quality Engineer or ISTQB credentials are widely recognized by Massachusetts employers, particularly in the life sciences and defense sectors, and give candidates a meaningful edge in competitive searches.
Which companies hire quality assurance engineers in Massachusetts?
Employers hiring quality assurance engineers in Massachusetts right now include Boston Scientific, Monogram Food Solutions, and Zoll Medical Corporation, based on current listings on Migrate Mate as of November 2026. Massachusetts's deep concentration of biotech, medical device, and defense contractors means quality assurance roles here often carry regulatory compliance requirements beyond what is typical in other states.
Which Massachusetts cities have the most quality assurance engineer jobs?
Boston, Waltham, and Burlington have the most quality assurance engineer openings in Massachusetts. The Greater Boston area drives the bulk of demand through its dense cluster of biotech, medical device, and technology employers, while cities like Marlborough and Waltham also generate significant volume thanks to established defense and life sciences campuses located along the Route 495 and Route 128 corridors.
Are there remote quality assurance engineer jobs in Massachusetts?
Yes, and more than many engineering disciplines, since software QA and test automation work can often be performed fully remotely. About 67% of quality assurance engineer openings tied to Massachusetts are remote or hybrid as of November 2026, though roles involving hardware validation, lab-based testing, or FDA-regulated manufacturing processes typically require on-site presence. Software-focused and automation-heavy positions carry the strongest likelihood of remote flexibility.
How can I get hired as a quality assurance engineer in Massachusetts with little or no experience?
The most realistic entry path is targeting associate QA analyst or junior test engineer roles at Massachusetts-based biotech and software companies, many of which hire recent graduates with relevant coursework or project portfolios. Large employers such as Philips Healthcare and MathWorks run structured new-grad programs that include quality and testing rotations. Candidates moving laterally from manual testing, technical support, or laboratory technician roles are frequently competitive, and earning an ISTQB Foundation certification before applying strengthens an entry-level profile considerably.
Where can I find and apply to quality assurance engineer jobs in Massachusetts?
You can find and apply to quality assurance engineer jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings updated regularly. Search the available roles, identify the ones that match your experience and specialty, and apply directly to the employers posting them.
See All 117+ Quality Assurance Engineer Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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