Senior Quality Operations Engineer - IVD/Regulatory
QUEST DIAGNOSTICS INC
QUEST DIAGNOSTICS INC seeks a Senior Quality Operations Engineer in Marlborough, MA. The role involves independent ownership of complex quality engineering activities while ensuring compliance with FDA and ISO standards. The candidate should have over 5 years of experience and a deep knowledge of quality systems in regulated environments. This position offers competitive pay and comprehensive benefits, contributing to a positive employee experience from Day 1. #J-18808-Ljbffr QUEST DIAGNOSTICS INC
- QUEST DIAGNOSTICS INC is seeking a Senior Quality Operations Engineer in Marlborough, Massachusetts. The role involves leading quality engineering activities and ensuring compliance with FDA and ISO regulations while mentoring junior engineers. The ideal candidate possesses...Senior
$90k - $110k
Quest Diagnostics Incorporated is seeking a Senior Quality Operations Engineer in Marlborough, MA, responsible for leading complex quality engineering activities. With a minimum of 5 years’ experience in regulated environments, the ideal candidate will manage investigations...Senior- Quest Diagnostics is looking for a Senior Quality Operations Engineer to independently lead complex quality engineering activities. This role involves process validation, investigations, and mentoring junior engineers within a regulated medical device environment. The...Senior
- ...global environment? Hologic is seeking a Senior Supplier Quality Engineer to support our Global Supplier... ...consistently meet stringent quality and regulatory requirements. In this role, you’ll assess... ...knowledge of medical device and IVD regulations, including: cGMP 21 CFR...SeniorRegulatoryWork at office
- QUEST DIAGNOSTICS INC is looking for a Staff Design Quality Engineer in Marlborough, Massachusetts. You will oversee quality for complex IVD medical devices, ensuring compliance with regulatory standards and guiding cross-functional teams. The ideal candidate will have...SeniorRegulatory
- QUEST DIAGNOSTICS INC is seeking a Senior Design Quality Engineer to oversee quality in IVD medical device development. The ideal candidate will have over 8 years in design quality and possess deep knowledge of relevant regulations like FDA QMSR and ISO 13485. The role...Senior
- Boston Scientific Gruppe is hiring a Supplier Quality Engineer III in Marlborough, MA. This role involves evaluating supplier quality issues, leading audits, and ensuring compliance with regulatory standards. The ideal candidate has a BS degree in engineering and experience...SeniorRegulatory
$93.04k - $123.23k
..., and competitive benefits. Job Summary The Senior Quality Engineer is responsible for developing, maintaining,... ...Engineering, Manufacturing, Supply Chain, and Operations to ensure product quality, process capability, regulatory compliance, and continuous improvement...SeniorRegulatoryTemporary work- Theuniversityunion is seeking a Sr. Design Quality Assurance Engineer to ensure compliance with all phases of the Product Lifecycle Process in... ...guarantee quality-engineering methodologies that meet company and regulatory standards. The ideal candidate will possess a Bachelor’s...SeniorRegulatoryFlexible hours
$89.2k
Job Summary The Senior Quality Systems Engineer supports the Global Quality Systems and Acquisition Integration... ...monitoring, documentation updates, regulatory implementation activities and issue... ...drive efficiency, scalability and operational excellence. Identify, analyze and...SeniorRegulatoryHourly payPermanent employmentRelocationRelocation packageShift work3 days per week- ...the life sciences industry. About the role As a Sr. Design Quality Assurance Engineer, you will ensure that all requirements are met for the... ..., systems, and practices that meet company, customer, and regulatory requirements. What You'll Do Provide quality and compliance...SeniorRegulatoryFor contractorsVisa sponsorshipWork visaFlexible hours
$89.2k
...of the Best Workplaces for Engineers in 2026, reflecting a culture... ...day. We are seeking a Senior Quality Systems Engineer to serve as... ...standards and global regulatory requirements. The incumbent... ...continuous improvement and operational excellence. ● Support the...SeniorRegulatoryHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$89.2k
...of the Best Workplaces for Engineers in 2026, reflecting a culture... ...day. We are seeking a Senior Quality Systems Engineer – Global Design... ...compliance with global regulatory requirements. This role... ...product quality, innovation and operational excellence across the...SeniorRegulatoryHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$145.9k - $234.2k
## Senior Engineer II, Automation, INTApplylocations: Norwood, Massachusetts... ..., Process Engineering, Quality, IT, Facilities, and other... ...per GDP standards Operational Excellence* Identify and implement... ...Strong background in CSV and regulatory compliance (21 CFR Part 11,...SeniorRegulatoryPermanent employmentFull timeWork at office$90k - $110k
...advancement opportunities · and so much more! The Senior Quality Operations Engineer, Quality Operations is an experienced quality engineering... ...production and process control activities supporting IVD design transfer, commercial manufacturing, and sustained...SeniorFull timePart timeFlexible hours$121.6k - $194.5k
...manufacturing facilities. The engineer will collaborate with cross-... ..., Facilities, MSAT, Quality, IT Infrastructure, Process... ...enterprise platforms including Operational Data Hub (ODH), Manufacturing... ...related to cGMP, GAMP, CSV, and regulatory requirements Develop and...SeniorRegulatoryPermanent employmentFull timeWork at officeLocal areaWork from home- A leading medical technology firm in Marlborough is seeking a Senior Supplier Quality Engineer to drive supplier excellence and compliance within a global context. This role involves assessing and qualifying suppliers, overseeing their quality practices, and leading improvements...Senior
- ...Strong communications skills with different Systems BU stakeholders in the US and with counterpart on the European side. Guides Engineering teams in the completion of certification work within a diverse and complex product portfolio. Strong knowledge of the safety and...SeniorTemporary workWork at office
- ...customers to assure best-in-class quality for product and provide... ...position corresponds to a Senior Quality Engineer. Duties and... ...plans, as needed. Assist in regulatory audit for customer accounts... ...with Supply Chain, PMs and Operations on managing the Material Review...SeniorRegulatory
$82.1k - $156k
Boston Scientific is looking for a Quality Engineer in Marlborough, MA, who will manage quality issues, evaluate supplier capabilities, and lead audits. The role supports the hybrid work model, requiring onsite presence for three days a week and two optional remote days...SeniorRemote work3 days per week- IPG Photonics, located in Marlborough, MA, is seeking a skilled compliance engineer to oversee technical communication with safety agencies while ensuring adherence to safety certifications such as UL, cUL, and CE. The ideal candidate should possess a BS in Electrical...Senior
- IPG Photonics in Marlborough, Massachusetts is looking for a Senior Quality Engineer responsible for developing and maintaining the Quality Management System for precision electro-mechanical products. The ideal candidate will support continuous improvement initiatives and...Senior
- ...Medical Corporation is seeking a Software Quality Engineer in Marlborough, MA with the following... ...deliverables meets the Quality and Regulatory requirements of FDA and ISO standards;... ...integration testing using C# within a Windows operating system to assess software updates,...RegulatoryLocal area
$128k - $191k
...Consultant - Utility Revenue Requirements Specialist in Marlborough, MA or Washington, DC with remote options. The role involves managing regulatory filings and providing expert analyses for utility clients across North America. The ideal candidate will have experience in...SeniorRegulatoryRemote job$82.1k
...responsibilities include Sustaining Engineering Evaluates and communicates quality issues to suppliers and applies... ...audits to assess compliance with regulatory standards and Boston Scientific... ...functional global teams spanning Quality, Operations, R&D, and Sourcing. Experience in...RegulatoryHourly payRemote workShift work- 327 Health & Home USA, Inc. is looking for a Senior Regulatory Specialist in Marlborough, MA, who will coordinate regulatory guidance and filings for medical devices and wellness products. The ideal candidate will have over 4 years of experience in regulatory affairs for...SeniorRegulatoryWork at officeRemote work
- IPG Photonics in Marlborough, MA is seeking a Compliance Engineer to drive safety certification and standards for laser products. Candidates should have a BS in Electrical Engineering and 5-10 years of relevant experience, particularly with UL, cUL, and CE certifications...Senior
$97.6k - $152.7k
Hologic, Inc. in Marlborough, MA is seeking a Senior Software Design Assurance Engineer to ensure the quality and regulatory compliance of medical device software. You will establish software design controls and drive verification and validation processes while collaborating...SeniorRegulatory- JPMorganChase in Hudson, Massachusetts, is looking for a Senior Home Lending Advisor to enhance homeownership dreams for clients. In... ...directly with clients to ensure exceptional service while adhering to regulatory requirements. The ideal candidate will have a background in...SeniorRegulatory
- Helen of Troy is looking for a Senior Regulatory Specialist based in Marlborough, MA. The role involves coordinating regulatory guidance for medical and wellness devices globally while ensuring compliance with FDA and international regulations. Successful candidates will...SeniorRegulatory
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