Global Device Quality & Risk Engineer
BioSpace
BioSpace in Cambridge, MA seeks a Device Quality Engineer to lead risk management, post‑market surveillance, and regulatory compliance for device and drug‑device products. You will own global processes, mentor teams, and ensure lifecycle resilience with ISO 14971, MDR, and 21 CFR 820. You will partner with quality, compliance, development, and manufacturing to enable transparency, patient safety actions, and lifecycle excellence across programs. #J-18808-Ljbffr BioSpace
$138k - $185k
About This Role As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical devices. This senior-level position requires you to work...SuggestedTemporary workLocal area$124k - $280k
...Requirements: Up to 60% At PwC, our people in risk and compliance focus on maintaining... ..., expertise, and network to deliver quality results. You motivate and coach others,... ...and manage strategy, transformation and engineering projects and teams Design and architect...SuggestedFull timeH1b- A leading medical device company in Boston is seeking a Quality Engineer to collaborate with various teams and uphold quality standards. The ideal candidate should have over 3 years of experience in Quality Engineering, a tertiary qualification in Science or Engineering...SuggestedFull time
- ...Quality Systems Engineer II Location: Boston, MA The Quality Systems Engineer II is responsible for helping and... ...Quality Systems organization from the Healthcare Device company location by ensuring compliance of the Global Quality Management System (QMS) with...Suggested
- ...innovative technology, to find a Design Quality Engineer. This is a chance to get in early at a... ...documentation review and traceability Risk management activities including hazard analysis... ...related field 4 to 7 years of medical device experience with a BS, or 3 to 6 years...Suggested
$114k - $182k
...Embedded Software Verification Engineer – Surgical Robotics (... ...image‑guided therapy within a global health‑technology organization... ...environments; experience with medical devices, safety‑critical systems,... ...everywhere has access to the quality healthcare that we all...Full timeWork at officeWork visaRelocation package3 days per week$133k - $186k
...Join to apply for the Senior Quality Assurance Engineer role at Morrison Foerster Join to apply for the... ...options and backup child and elder care. Global wellness program, including free... ...Quality Assurance Engineer - Medical Device Concord, MA $110,000.00-$120,000.00 1...Full timeWork experience placementLocal areaRelocation- A technology company in Boston is seeking a full-time Quality Engineer to ensure compliance with ISO9001 standards and support tactical processes. The ideal candidate will have a Bachelor’s degree in Engineering and experience in an ISO-regulated environment. This role...Full time
- A growing medical device company is seeking a Senior Quality Engineer to lead design quality for new product development. This role requires collaboration with... ...device quality. Strong skills in design controls and risk management are essential, along with excellent...Full time
- ...Opportunity In this exciting role as a Quality Engineer – Manufacturing, you'll actively collaborate... ...in Quality Engineering in the medical device industry. A tertiary qualification in... ..., exporting to over 120 countries globally. Our commitment to care unites us. Here...Full timeWork experience placementRelocation package
- A leading medical device firm is seeking a Contract Test Engineer in Boston, Massachusetts. The ideal candidate will have over 5 years of experience in test engineering specifically for electro-mechanical medical devices, alongside a robust background in V&V testing. Responsibilities...Contract work
$62.8k
...Scientific ranked #2 among medical device companies on Forbes America's Best Places to Work for Engineers 2026. Whether your passion... ...of a highly effective product quality team. You\'ll work side-by-... ...values to everything we do - as a global business and as a global...Hourly payWork at officeLocal areaImmediate startWorldwideRelocationRelocation packageShift work3 days per week- Spryte Medical, LLC. is seeking a Quality Engineer located in Bedford, Massachusetts. This role is crucial for ensuring that catheter and console... ...have at least 5 years of experience in sterile disposable device engineering, strong communication skills, and a bachelor’s...Permanent employmentContract workTemporary work
- ...located in Needham, Massachusetts, is seeking a Product Compliance Engineer to oversee product certification processes. This includes... ...engineers and certification partners to ensure compliance with medical device regulations. The ideal candidate will have a bachelor's degree...
$115k - $182k
...Job Title Software Test Engineer - Medical Device Integration (Bedford, MA)... ...successfully implements effective risk control measures. Your... ...and testable. Supports high-quality delivery by validating requirements... ...collaborating with global software development teams and...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$135k - $160k
...Development (Design Assurance) Quality Engineer A long term client company of... ...strategic partnership with a global medtech and is experiencing... ...the Design Control and design-risk-management processes across... ..., and software-based medical devices. This is a hands‑on design‑quality...$98k - $123k
...Description Sirtex Medical is a global leader in healthcare, with... ...Description The Senior Supplier Quality Engineer (Sr. SQE)is responsible... ...manufacturers supporting medical device production. This... ...mitigating supplier-related risks. NOTE: Candidates must be local...Contract workWork at officeLocal areaRemote workWorldwide2 days per week3 days per week- ...Supplier Qualifications, Audits, Quality Assurance Agreement negotiations, and Supplier Risk Improvement. This role is... ...escalation path for supplier quality engineering part-level concerns. Job... ...a related field. FDA & Medical Device experience. Must be fluent in English...Work at officeLocal area
$90k - $110k
...serves as the U.S.-based quality and regulatory lead,... ...compliance with medical‑device regulations while overseeing... ...‑to‑end oversight of global manufacturing partners... ...using cutting‑edge engineering, modeling, and manufacturing... .... Strong skills in risk management (ISO 14971),...Local area- ...About the role: Elemental Machines is seeking an experienced and organized full‑time Quality Engineer to join our team in the development of industry‑leading IoT devices and sensors. In this position, you will support the tactical processes used by EM to ensure our development...Full timeContract work
$70k - $120k
...The Role We’re hiring Quality Engineers to work at Veeva, working on various products in the Life... ..., biotechnology, and medical devices. As part of our Quality Assurance and Release... ...reports assessing quality and associated risk. Develop deep expertise in the product....Work experience placementLocal areaFlexible hours- ...Overview: Our client, a rapidly growing medical device company specializing in catheter devices, is seeking a self-driven Quality Engineer to support their expanding operations. This... ...equipment, processes, and product. Perform risk management activities including FMEA and...
$160k - $200k
...The Principal Compliance Engineer is the Hemostasis and... ...partners with Regulatory and Quality Depts. to ensure... ...technical positions for global market access across Hemostasis... ...interpretation, risk based decisions, retest... ...committees. Medical device and/or IVD instrumentation...Work experience placementWorldwide- ...Quality Engineer Position Overview We are seeking a Quality Engineer to join our team and... ...cross-functional teams to identify quality risks and implement process improvements.... ...regulated manufacturing environment, including medical device or related industries....Work at office
- ...Quality Complaint Investigation We are seeking a Quality Complaint... ...within a regulated medical device manufacturing environment.... ...associated service data to determine risk levels and identify problem/... ...~ Bachelor's Degree in Engineering (B.E./B.Tech or equivalent)....
$156k - $234k
...opportunity within the Security Trust and Risk (STAR) team whose mission is to ensure... ...environment. The STAR team assists the Global Security Services (GSS) organization in developing... ...: The Lead Security Governance & Risk Engineer is a senior, hands‑on role at the point...$84k - $156k
...We are looking for a Quality Engineer who is excited about space and technology applications to join the L3Harris Imaging Division in Wilmington... ...program ( ) and created the first laser communication device outside the Earth-Moon system ( Deep Space Optical Communications...Contract workFor subcontractorLocal areaFlexible hours$72.7k - $111.4k
...Overview SharkNinja is a global product design and... ...in. Product Compliance Engineer The Product Compliance... ...incorporate appropriate risk mitigation solutions. This... ...participation in medical device regulatory pathways... ...Medical Devices ISO 13485 – Quality Management Systems IEC...Temporary workLocal areaWorldwideFlexible hoursShift work$85k - $105k
...Cumulus is a Quality Management System (QMS) that ensures critical construction and maintenance... ...AI-powered workflows and connected IoT devices, the Cumulus QMS improves the... ...100 list The Role As a Software Quality Engineer at Cumulus, you will be embedded within...Work at officeRemote work- ...eInfochips is a product engineering and software R&D services company with over 20+ years of... ...and 80% from solutions around connected devices. Founded in 1994, our work culture is built... ...our success lies upon the skills and quality of our people we work with. Today, we are...
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