Quality Engineer Jobs in Massachusetts
Quality Engineer jobs in Massachusetts are in strong demand, concentrated in the state's large medtech, defense, aerospace, and biopharma sectors, with openings at every level from entry-level quality technician through senior and principal engineer. The most active hiring is in the Greater Boston corridor, Worcester, and the Route 128 technology belt, where employers like Raytheon Technologies, Boston Scientific, and Bristol Myers Squibb maintain significant quality engineering headcounts. The most sought-after specialties include ISO 13485 and FDA regulatory compliance, supplier quality, and process validation. Find a role that fits below and apply directly.
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Job Description:
POSITION SUMMARY
We are seeking a highly skilled and experienced Senior Software Quality Engineer to join our team. The ideal candidate will have a strong background in computer system validation, quality processes and IT, with a proven track record of successfully implementing software and IT systems. This role sits within Quality but works in close partnership with IT to implement and support systems that enable compliant, efficient, and scalable business processes.
The ideal candidate will bring a strong balance of technical aptitude and quality systems expertise, with the ability to independently execute system configurations, lead validation activities, and translate business needs into practical, compliant system solutions.
RESPONSIBILITIES
- Lead configuration, setup, and deployment of enterprise software systems supporting Quality and cross-functional processes.
- Perform independent review and approval of software validation documentation (e.g. plans, protocols, reports) as the Quality representative, ensuring compliance with regulatory and internal requirements.
- Partner closely with IT to support system integrations, data structures, access controls, and technical troubleshooting.
- Translate business and quality process requirements into system configurations, workflows, and scalable solutions.
- Lead and execute system validation activities (e.g., IQ/OQ/PQ, UAT), ensuring compliance with applicable regulatory requirements.
- Troubleshoot system issues, perform root cause analysis, and implement Support data migration, data integrity checks, and system updates/enhancements.
- Drive system testing efforts, including test strategy, defect tracking, and resolution
- Collaborate with cross-functional teams to manage dependencies and ensure seamless integration.
- Attend meetings, engage with consultants, and provide granular-level guidance
Qualifications
- 5+ years of experience implementing or supporting enterprise software systems (e.g. QMS, ERP, PLM, MES or similar platforms).
- Strong working knowledge of quality system processes (e.g., CAPA, complaints, audits, change control) in a regulated environment.
- Hands-on experience with system configuration, testing, validation, and troubleshooting.
- Experience with software validation principles (CSV/CSA) and data integrity requirements.
- Proven ability to work cross-functionally with both technical (IT) and non-technical stakeholders.
- Strong problem-solving skills with the ability to diagnose issues and independently drive resolution.
- Ability to manage multiple priorities and drive work forward in a fast-paced environment.
- Strong communication and collaboration skills.
Preferred Requirements
- Experience in medical device, pharmaceutical, or other regulated industries.
- Experience supporting system integrations and working with APIs or data interfaces (high-level understanding).
- Experience with digital transformation initiatives and large-scale system implementations.
- Experience supporting global or multi-site system deployments.
- Ability to mentor others and provide technical guidance within the Quality
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.
Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.
Maximize your potential at TransMedics, Inc.
www.TransMedics.com
TransMedics is committed to equitable and transparent compensation. The expected salary for this role is $95,000 - $110,000 which represents the company’s current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.
Employee Benefit:
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
See All 238+ Quality Engineer Jobs in Massachusetts
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Find Quality Engineer JobsQuality Engineer Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Quality Engineer Job Market in Massachusetts
A snapshot from current Massachusetts openings, updated as new roles post.
Who's Hiring
- Katalyst Healthcares & Life Sciences23

- Raytheon16

- VulcanForms9

- Teleflex7

- Whoop5

Top Industries Hiring
- Consulting & Professional Services
- Manufacturing
- Medical Devices
- Chemicals & Materials
- Electronics & Hardware
What Massachusetts Employers Look For
The qualifications that appear most often in quality engineer jobs across Massachusetts.
- Bachelor's degree in engineering, manufacturing, or a related technical field required
- ASQ Certified Quality Engineer (CQE) credential strongly preferred by Massachusetts employers
- Experience with FDA 21 CFR Part 820 or ISO 13485 for medical device or biopharma roles
- Proficiency with statistical process control tools such as Minitab or equivalent software
- Familiarity with DFMEA, PFMEA, CAPA, and root cause analysis methodologies
- Working knowledge of AS9100 or NADCAP standards for aerospace and defense roles
Quality Engineer Jobs in Massachusetts: Frequently Asked Questions
How do you become a quality engineer in Massachusetts?
Massachusetts does not require a state-issued license to work as a quality engineer, so the path focuses on education and professional credentials. Most employers expect a bachelor's degree in mechanical, industrial, biomedical, or a related engineering discipline. The ASQ Certified Quality Engineer (CQE) exam is the most recognized credential and is weighted heavily by Massachusetts medtech and defense employers. Candidates targeting regulated industries like medical devices should also study FDA quality system regulations early in their career.
Which companies hire quality engineers in Massachusetts?
Employers hiring quality engineers in Massachusetts right now include Katalyst Healthcares & Life Sciences, Raytheon, and VulcanForms, based on current listings on Migrate Mate as of November 2026. Massachusetts's deep concentration of medical device, biopharma, and defense contractors means quality engineer demand is spread across large multinationals and specialized mid-size manufacturers anchored along the Route 128 corridor and greater Boston area.
Which Massachusetts cities have the most quality engineer jobs?
The cities with the most quality engineer openings in Massachusetts are Boston, Andover, and Devens. Boston and its immediate suburbs drive the largest share because of the region's dense biopharma and medtech cluster, while Worcester and smaller Route 128 communities reflect the manufacturing and defense contractors that have operated there for decades, pulling quality engineering talent away from the metro core.
Are there remote quality engineer jobs in Massachusetts?
Yes, but they're rare. Quality engineering is largely a hands-on discipline requiring physical presence on the production floor, in supplier facilities, or in laboratory environments, so full remote positions are uncommon. About 43% of quality engineer openings tied to Massachusetts are remote or hybrid as of November 2026, and those postings tend to cover supplier quality auditing, documentation, or quality systems roles that can be done without daily on-site work.
How can I get hired as a quality engineer in Massachusetts with little or no experience?
The most realistic entry path is a quality technician or quality assurance associate role, which large Massachusetts medtech and defense manufacturers use as a direct pipeline into quality engineering. Employers like Boston Scientific and Raytheon Technologies run structured new-graduate and rotational programs that include quality functions. Candidates who complete an ASQ Certified Quality Improvement Associate (CQIA) credential or finish a co-op through a Massachusetts engineering program gain a measurable edge when competing against others with similar degree backgrounds.
Where can I find and apply to quality engineer jobs in Massachusetts?
You can find and apply to quality engineer jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across medtech, aerospace, defense, and biopharma employers. Find roles that fit your experience and specialization and apply directly through the listings on this page.
See All 238+ Quality Engineer Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Quality Engineer Jobs