Medical Device Quality Assurance Engineer – Marlborough, MA Position Available In Middlesex, Massachusetts

Medical Device Quality Assurance Engineer – Marlborough, MA IPG Photonics United States, Massachusetts, Marlborough Jun 18, 2025 Back
Medical Device Quality Assurance Engineer
#25-133 | Posted 03/17/2025
Marlborough, Massachusetts, United States
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Job Description IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life. Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society. Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits. Duties Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues
Assist with maintenance of calibration system
Support Manufacturing Engineering in the creation, release and maintenance of DHR, routers, bills of material, and specifications for manufacturing
Support Product development activities and design transfer into manufacturing
Perform incoming inspection review and disposition of product components and subsystems
Develop and/or revise routine procedures, work instructions, and test methods.
Document all activities in compliance with applicable medical standards, regulations, and guidelines.
Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
Support management of new and approved suppliers; participate in internal and supplier audits.
Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
Make decisions and propose solutions based on calculated risks identified through data analysis. Requirements Must have 3 – 5 years of manufacturing quality experience within the medical device industry
Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred
Extensive working knowledge of 21 CFR 820 and

ISO 13485

Strong working knowledge of Microsoft Word and Excel
Hands-on experience with any of the following manufacturing processes: Electro-mechanical assembly, ESD controls, Cabling, Clean room, Labeling, sterilization
Experience executing process validation and test method validation/Gage R&R activities
Strong documentation capability for protocol and report generation and review
Prior start-up experience is a plus Location(s)
225 Cedar Hill Road, Marlborough , Massachusetts 01752 , United States
Employment Type
Exempt