Senior Quality Engineer - Med Device, FDA-Regulated
Jobleads-US
JobDiva, Inc. urgently seeks a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. You will lead quality engineering efforts, manage transfers and validation activities, and ensure compliance with PFMEA, CAPA, and ISO 13485 requirements.
Ideal candidates have extensive experience with IQ/OQ/PQ validation, FDA 21 CFR Part 820, and robust technical writing skills to maintain compliant documentation and support audits.
#J-18808-Ljbffr Jobleads-US- ...Summary: We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. Roles & Responsibilities: ~10+ years of Quality Engineering experience in medical device manufacturing. ~ Strong experience...SeniorContract work
$95.9k - $129.47k
...Olympus: .Job DescriptionThe Product Quality Engineer is responsible for the design, development... ...policies and procedures and medical device regulations. The Product Quality Engineer will... ...experience in Quality Engineering within an FDA regulated medical device manufacturing...SeniorFull timeLocal areaWorldwideFlexible hours$95.9k - $129.47k
...: Job Description The Product Quality Engineer is responsible for the design, development... ...policies and procedures and medical device regulations. The Product Quality Engineer will... ...experience in Quality Engineering within an FDA regulated medical device manufacturing...SeniorFull timeLocal areaWorldwideFlexible hours- ...provide supply chain and test engineering expertise for all CVRx... ...internal audits for compliance to regulations and CVRx SOPs. Develop and... ...more experience in a medical device company Experience as an engineer... ...languages Knowledge of FDA QSR and ISO 13485 regulatory...SeniorWork at officeLocal areaFlexible hours
$95.9k - $129.47k
...: Job Description The Product Quality Engineer is responsible for the design, development... ...policies and procedures and medical device regulations. The Product Quality Engineer will... ...experience in Quality Engineering within an FDA regulated medical device manufacturing...SeniorFull timeLocal areaWorldwideFlexible hours- ...Spencer Gregory HaleSenior Quality Engineer - Boston Scientific Cardiac... ...this role:We are seeking a Senior Quality Engineer to provide... ...systems and practices against regulations and company documentation.Participate... ...System Regulations, Medical Device Regulation, and ISO 13485...SeniorHourly payShift work
- ...of the Best Workplaces for Engineers in 2026, reflecting a culture... ...employees experience every day.The Senior Quality Engineer will lead and... ...against applicable regulations and company documentation.Apply... ...healthcare. Our portfolio of devices and therapies helps physicians...SeniorHourly payWork at officeLocal areaRelocationRelocation packageShift work
- ...Job summary: We are seeking a Senior Quality Engineer – Quality Systems to support and drive quality system activities within a regulated medical device manufacturing environment. The ideal candidate... ...and documentation comply with FDA 21 CFR 820, ISO13485, ISO 14971,...Senior
- ...Job Description Our client is seeking a Quality Engineer III – Molding to provide senior-level quality engineering support within a regulated manufacturing environment. This role... ...quality engineering. Experience in medical device or other regulated manufacturing...RelocationVisa sponsorship
- ...Senior Quality Assurance EngineerThe Senior Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible... ...requirements, such as FDA, ISO 13485 standards.... ...in IVD, Medical Device, or Biotechnology organization... ...US and International regulations and standardsFamiliar...SeniorLocal area
$78k - $156k
...products in diagnostics, medical devices, nutritionals and branded... ...on with their lives.As a Senior Engineer, you will be providing... ...projects including quality improvement initiatives.Sets... ...inspections and inquiries from regulators such as FDA and ISO as it relates to...SeniorFor contractorsShift work$85k
...Recruiter: Spencer Gregory Hale Senior Supplier Quality Engineer – SFMD About the role: The Sourced Finished Medical Device (SFMD) organization at Boston... ...aeronautical, semiconductor, or other regulated industry. Project management: the ability...SeniorHourly payShift work$85k
...the Best Workplaces for Engineers in 2026, reflecting a... ...We are seeking a Senior Quality Engineer to support our... ...support compliance with FDA and other global regulatory... ...with medical device regulatory requirements... ...related role within a regulated industry, preferably medical...SeniorHourly payWork at officeLocal areaShift work3 days per week$100k - $125k
...and manufacture world-class medical devices across the full product lifecycle. From... ...improve lives worldwide. The Sr;. Quality Assurance Engineer is responsible for operational... ...with the Quality System and relevant regulations and standards, continuous improvement...SeniorTemporary workWorldwide- ...Senior Recruiter at Staftonic, Passionate about connecting... ...Position: Sr. Supplier Quality Engineer Location: Minneapolis, MN... ...Quality Engineering within a regulated industry (Medical Device experience strongly... ...knowledge of ISO 13485 , FDA QSR , and supplier quality...SeniorContract work
$115k - $150k
...Join to apply for the Senior Quality Engineer role at Real We're hiring a Senior Quality Engineer for a leading medical device company in Minneapolis, MN. Base Pay Range $115,0... ...Role Highlights Ensure compliance with FDA, ISO 13485, EU MDR Lead CAPA...SeniorFull time$93.82k - $174.23k
...world’s oldest enemy: disease. The Sr. Quality Engineer works under minimal supervision to provide... ...with cGMP, relevant ICH and Global regulations. This role will support the execution of... ...Participate in third party (Notified Body, FDA,) audits as required. Supports high-...SeniorFull timeTemporary workLocal areaFlexible hours$85k
...one of the Best Workplaces for Engineers in 2026, reflecting a culture... ...will participate in medical device software verification and... ...engineer with a strong focus on quality and expertise in requirements... ...progress and quality reports to senior management. Lead root...SeniorHourly payWork at officeRelocationRelocation packageShift work3 days per week$85k - $110k
...New Hope, Minnesota is looking to hire a senior quality engineer to join their team. This Sr Quality... ...Haves: ~5-8 years of experience in ISO/FDA medical manufacturing environment ~ Bachelor... ...with Class II or Class III medical device contract manufacturing complex...SeniorContract work$80k - $100k
...Job Title: Quality Engineer Job Description The Quality Engineer plays a key role... ...customers, and ensures compliance with ISO, FDA, and other applicable standards. The... ...to maintain high-quality output in a regulated medical device environment. Responsibilities...Permanent employmentFull timeTemporary workPart timeCasual workFlexible hours- ...Job 2830 - Quality Engineer - Contract located near Minneapolis, Minnesota... ...(MEC) support medical device and pharmaceutical companies... ...close gaps between current and FDA expected stages. MEC offers... ...internal procedures, applicable regulations, and company standards....Contract workTemporary work
$110k - $125k
...manufacture world-class medical devices across the full product... ...manufacturing, supply chain, and quality teams to assess, onboard, and... .... The supplier quality engineer is the primary liaison to Nextern... ...Quality System and relevant regulations and standards, continuous improvement...SeniorTemporary workWorldwide$125k - $170k
...Minneapolis is looking for a Senior Environmental Air Specialist... ...function as a lead on air quality impact analyses and client needs... ...experience or related Engineering degree from an accredited program... ..., state, and local air regulations with emphasis on the Clean Air...SeniorFull timeFor contractorsWork experience placementLocal area$85k
...of the Best Workplaces for Engineers in 2026, reflecting a culture... ...experience every day. The Senior Quality Engineer will lead and... ...practices against applicable regulations and company documentation.... ...healthcare. Our portfolio of devices and therapies helps physicians...SeniorHourly payWork at officeLocal areaRelocationRelocation packageShift work$82.6k
...of the Best Workplaces for Engineers in 2026, reflecting a culture... ...this time, we are seeking a Senior Quality Engineer to support the manufacturing... ..., high-quality drug-device combination therapies for... ...practices against applicable regulations and internal procedures. ●...SeniorHourly payWorldwideRelocationRelocation packageShift work- ...Job Description Job Description Senior Air Quality Specialist / Engineer – Environmental Services Location: Minneapolis, MN Travel: ~10% Competitive... ...consulting ~ Strong experience with Clean Air Act regulations and permitting requirements ~ Experience with air...Senior
- ...:Boston Scientific is currently recruiting for a Design Quality Engineer II at our Arbor Lakes campus in Maple Grove, MN. This is... ...of experience in an engineering role within medical device or similar regulated industry Knowledge of Quality System Requirements, Good...Hourly payRelocation packageShift work3 days per week
- ...Job Description Position Summary The Quality Engineer III will be responsible for providing... ...company Quality System, ISO, and medical device requirements Read, understand, and follow... ...Experience in injection molding Experience in the med device industry...Temporary workWork at office
- ...Sr Quality EngineerLocation: Minneapolis Minnesota (Onsite) Duration: 08 Months Pay Rate... ...W2Key Requirements:4+ years of Quality Engineering experience in medical devicesStrong Design... ...compliance experience in a medical-device environmentExperience with Lean / Six Sigma...Senior
- ...great healthcare is an essential safeguard of human dignity. Who We're Looking For: As a key member of the Quality Team, the Senior Supplier Quality Engineer will be to manage product quality through the implementation of supplier/contract manufacturer evaluation...SeniorContract workFlexible hours
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