Medical Devices H-1B Sponsorship Jobs in Massachusetts
Massachusetts is one of the strongest states for medical devices H-1B visa sponsorship, anchored by major employers like Boston Scientific, Medtronic, and Hologic concentrated around Boston, Marlborough, and the Route 128 corridor. The state's density of teaching hospitals, biomedical research institutions, and device-focused startups creates consistent demand for sponsored engineering, regulatory, and clinical roles.
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Get Access To All JobsJob Summary:
The Sr. Quality Control Manager is responsible for leading and scaling Quality Control (QC) operations across multiple U.S. manufacturing facilities in Waltham, Norwood, and Billerica, Massachusetts, supporting the production of biotechnology and clinical systems, including point-of-care (POC) and in vitro diagnostic (IVD) medical devices, consumables, and reagents.
This role ensures product quality, regulatory compliance, and operational excellence throughout the manufacturing lifecycle, with a strong emphasis on data-driven quality management, statistical monitoring, and continuous improvement. The Sr. Quality Control Manager will develop and execute comprehensive quality control strategies that support FDA medical device requirements, MDSAP, IVDR, ISO 13485, ISO 14971, and other applicable regulatory standards while enabling scalable growth across the organization.
The ideal candidate will be a collaborative leader who partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and Operations leadership to drive quality objectives, business expansion, and commercialization goals.
Responsibilities:
- Lead Quality Control functions across multiple manufacturing and distribution sites within the United States.
- Establish and maintain enterprise-wide QC strategies, policies, procedures, and performance metrics.
- Build, develop, and mentor high-performing Quality Control teams while fostering a culture of accountability, compliance, and continuous improvement.
- Ensure consistency of QC practices, testing methodologies, and inspection standards across all facilities.
- Drive operational excellence initiatives that improve product quality, efficiency, and scalability.
- Establish robust systems for collecting, monitoring, analyzing, and reporting product quality and manufacturing performance data.
- Proactively identify trends, emerging product risks, recurring defects, process shifts, and performance gaps to support continuous improvement.
- Lead root cause investigations using structured problem-solving methodologies and statistical tools.
- Analyze quality, yield, reliability, complaint, nonconformance, and production output data to improve product performance and manufacturing capability.
- Ensure compliance with FDA, MDSAP, IVDR, ISO, and other applicable regulatory requirements and harmonized standards.
- Oversee the management of documentation, records, test reports, deviations, investigations, CAPAs, and quality metrics.
- Collaborate with R&D, Supplier Quality, Incoming Inspection, Manufacturing, Manufacturing Engineering, Finished Goods, and Distribution teams to drive quality improvements.
- Support engineering and manufacturing quality initiatives through the effective use of procedures, processes, quality engineering tools, and data analysis.
Experience Requirements:
- Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820.
- Experience developing product and process trend analyses, nonconformance reduction programs, risk reduction initiatives, cost containment efforts, and executive-level quality reporting.
- Experience applying product lifecycle risk management principles for IVD medical devices.
- Experience linking QC trends, nonconformances, complaint investigations, and manufacturing performance data to product risk management activities.
- Experience with process and equipment validation activities, including authoring and reviewing IQ, OQ, and PQ documentation.
- Experience authoring Quality Plans and Quality Control Plans.
- Experience supporting multi-site manufacturing operations.
- Strong project management, leadership, and team development skills.
- Bachelor's degree or higher in a technical discipline, preferably within Life Sciences, Chemistry, Medical Technology, or a related field.
- 5–10 years of Quality Control management experience within an FDA-regulated medical device, IVD, or reagent manufacturing environment.
- ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Green Belt Six Sigma certification preferred.
Physical Requirements and Working Conditions:
- Ability to travel between manufacturing facilities as needed.
- Ability to wear required Personal Protective Equipment (PPE).
- Ability to stand or sit for extended periods.
- Ability to work in front of a computer screen for prolonged periods.
- Ability to lift up to 35 pounds.
Why Work for Nova Biomedical
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
Work Location: Waltham, MA
Targeted Salary Range: $150,000-$170,000/yr
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.
At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.
Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.
Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Job Summary:
The Sr. Quality Control Manager is responsible for leading and scaling Quality Control (QC) operations across multiple U.S. manufacturing facilities in Waltham, Norwood, and Billerica, Massachusetts, supporting the production of biotechnology and clinical systems, including point-of-care (POC) and in vitro diagnostic (IVD) medical devices, consumables, and reagents.
This role ensures product quality, regulatory compliance, and operational excellence throughout the manufacturing lifecycle, with a strong emphasis on data-driven quality management, statistical monitoring, and continuous improvement. The Sr. Quality Control Manager will develop and execute comprehensive quality control strategies that support FDA medical device requirements, MDSAP, IVDR, ISO 13485, ISO 14971, and other applicable regulatory standards while enabling scalable growth across the organization.
The ideal candidate will be a collaborative leader who partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and Operations leadership to drive quality objectives, business expansion, and commercialization goals.
Responsibilities:
- Lead Quality Control functions across multiple manufacturing and distribution sites within the United States.
- Establish and maintain enterprise-wide QC strategies, policies, procedures, and performance metrics.
- Build, develop, and mentor high-performing Quality Control teams while fostering a culture of accountability, compliance, and continuous improvement.
- Ensure consistency of QC practices, testing methodologies, and inspection standards across all facilities.
- Drive operational excellence initiatives that improve product quality, efficiency, and scalability.
- Establish robust systems for collecting, monitoring, analyzing, and reporting product quality and manufacturing performance data.
- Proactively identify trends, emerging product risks, recurring defects, process shifts, and performance gaps to support continuous improvement.
- Lead root cause investigations using structured problem-solving methodologies and statistical tools.
- Analyze quality, yield, reliability, complaint, nonconformance, and production output data to improve product performance and manufacturing capability.
- Ensure compliance with FDA, MDSAP, IVDR, ISO, and other applicable regulatory requirements and harmonized standards.
- Oversee the management of documentation, records, test reports, deviations, investigations, CAPAs, and quality metrics.
- Collaborate with R&D, Supplier Quality, Incoming Inspection, Manufacturing, Manufacturing Engineering, Finished Goods, and Distribution teams to drive quality improvements.
- Support engineering and manufacturing quality initiatives through the effective use of procedures, processes, quality engineering tools, and data analysis.
Experience Requirements:
- Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820.
- Experience developing product and process trend analyses, nonconformance reduction programs, risk reduction initiatives, cost containment efforts, and executive-level quality reporting.
- Experience applying product lifecycle risk management principles for IVD medical devices.
- Experience linking QC trends, nonconformances, complaint investigations, and manufacturing performance data to product risk management activities.
- Experience with process and equipment validation activities, including authoring and reviewing IQ, OQ, and PQ documentation.
- Experience authoring Quality Plans and Quality Control Plans.
- Experience supporting multi-site manufacturing operations.
- Strong project management, leadership, and team development skills.
- Bachelor's degree or higher in a technical discipline, preferably within Life Sciences, Chemistry, Medical Technology, or a related field.
- 5–10 years of Quality Control management experience within an FDA-regulated medical device, IVD, or reagent manufacturing environment.
- ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Green Belt Six Sigma certification preferred.
Physical Requirements and Working Conditions:
- Ability to travel between manufacturing facilities as needed.
- Ability to wear required Personal Protective Equipment (PPE).
- Ability to stand or sit for extended periods.
- Ability to work in front of a computer screen for prolonged periods.
- Ability to lift up to 35 pounds.
Why Work for Nova Biomedical
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
Work Location: Waltham, MA
Targeted Salary Range: $150,000-$170,000/yr
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.
At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.
Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.
Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
H-1B Medical Devices Job Roles in Massachusetts
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Search Medical Devices Jobs in MassachusettsMedical Devices H-1B Sponsorship Jobs in Massachusetts: Frequently Asked Questions
Which medical devices companies sponsor H-1B visas in Massachusetts?
Several large medical devices companies with significant Massachusetts operations have established H-1B visa sponsorship histories, including Boston Scientific (headquartered in Marlborough), Hologic (Marlborough), Medtronic, and Stryker. Beyond these, the Boston area hosts a dense cluster of device-focused startups and subsidiaries of global medtech firms that regularly file H-1B petitions for engineering, regulatory, and R&D roles.
Which cities in Massachusetts have the most medical devices H-1B sponsorship jobs?
The Route 128 corridor, particularly Marlborough, Natick, and Waltham, is the geographic center of Massachusetts medical devices hiring. Greater Boston, including Cambridge and Woburn, concentrates device-adjacent roles tied to research hospitals and biotech-medtech crossover companies. Worcester also has a growing medical devices presence connected to UMass Medical School and regional manufacturers.
What types of medical devices roles typically qualify for H-1B sponsorship?
H-1B sponsorship in medical devices most commonly covers roles that require at least a bachelor's degree in a specific technical field. These include hardware and software engineering for device development, regulatory affairs (requiring knowledge of FDA 510(k) or PMA pathways), quality assurance and systems engineering, clinical applications specialists with relevant clinical science degrees, and R&D scientists in biomechanics or biomedical engineering.
How do I find medical devices H-1B sponsorship jobs in Massachusetts?
Migrate Mate is built specifically for international candidates seeking visa sponsorship roles, making it a practical starting point for medical devices H-1B jobs in Massachusetts. You can filter directly by visa type and state to surface companies with active sponsorship histories in the Massachusetts device sector, rather than sorting through listings where sponsorship availability is unclear.
Are there any Massachusetts-specific considerations for H-1B sponsorship in medical devices?
Massachusetts enforces some of the strongest employee non-compete protections in the country, and the state's proximity to top research universities like MIT, Harvard, and WPI means employers often have established international hiring pipelines. FDA-regulated device companies in the state also tend to have in-house legal or HR teams experienced with H-1B filings, since regulatory and engineering talent is frequently recruited globally.
What is the prevailing wage for H-1B medical devices jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.