Senior Medical Device Auditor: ISO 13485, MDSAP, QMSR
Quality Auditing LLC
Quality Auditing LLC seeks an experienced Medical Device Auditor for contract work in the greater Minneapolis area. The role focuses on conducting thorough first- and second-party quality system audits against ISO 13485, MDSAP, FDA QMSR, and EU MDR, with professional opening/closing meetings and precise reporting. Ideal candidates bring 10+ years in medical device auditing, 50+ audits as Lead/Solo auditor, and strong English communication. #J-18808-Ljbffr Quality Auditing LLC
- A leading recruiting firm is seeking a Senior Supplier Quality Engineer in Minneapolis... ...and management within the medical device industry. The ideal candidate will have... ...engineering, with a strong knowledge of ISO 13485 and FDA regulations. #J-18808-Ljbffr Staftonic...SeniorMedical deviceLong term contract
- ...experience every day.The Senior Quality Systems Engineer serves... ..., preferably within the medical device industry. Demonstrated... ...Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971 and other... ...CQE), ASQ Certified Quality Auditor (CQA) or an equivalent professional...SeniorMedical deviceHourly payWork at officeLocal areaRelocationRelocation packageFlexible hoursShift work3 days per week
- Brio Group is seeking a Senior Quality Engineer to provide leadership and technical support in a regulated medical device environment. The role focuses on manufacturing quality,... ...regulated manufacturing, with strong knowledge of FDA and ISO 13485. #J-18808-Ljbffr Brio GroupSeniorMedical device
- ...Senior Quality Engineer We are urgently seeking a Senior Quality Engineer with strong... ...hands-on experience in FDA-regulated medical device manufacturing. Roles & Responsibilities... ...& CAPA. # Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management...SeniorMedical deviceContract work
- ...Senior Buyer We believe that great healthcare is an essential safeguard of human... ...related professional certification Medical device, life sciences, or other regulated manufacturing... ...including experience working within an ISO 13485 environment Experience supporting...SeniorMedical device
- Senior R&D Engineer - Medical Devicesð Are you passionate about designing products that... ...with an innovative medical device organization seeking a Senior... ...with FDA regulations, ISO standards, design controls,... ...SolidWorksFDA Design Controls and ISO 13485 Quality Management...SeniorMedical deviceWorldwide
- ...Senior Quality Assurance Engineer The Senior Quality Assurance Engineer for Beckman... ...regulatory requirements, such as FDA, ISO 13485 standards. Ensure the product Design... ...with 5+ years' experience in IVD, Medical Device, or Biotechnology organization preferred...SeniorMedical deviceLocal area
- ...management, design controls, and compliance. Candidates with medical device experience are highly preferred; however, experience in other... ...compliance with applicable regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC standards as applicable). Participate in...SeniorMedical deviceWork at office
$170k
Please see the below requirements for a Senior or Principal Electrical Engineer to join a growing class III medical device organization in the Northeast Twin Cities Metro. This... ...working in a regulated environment (FDA/ISO) medical device experience strongly preferredComfortable...SeniorMedical device$110k - $127.5k
...Endologix LLC is a California-based global medical device company dedicated to improving... ...Engineering and works day to day with senior Quality and R&D team members on site.... ...development programs, ensuring compliance with ISO 13485:2016, QMSR (21 CFR Part 820), and other...SeniorMedical deviceFor contractorsLocal areaWork from homeFlexible hours$80k - $200k
...in Complaints Management for Medical DeviceStrong understanding of... ...Management processesKnowledge of ISO 13485 and 14971, FDA 21CFR Part 80... ...experienceClinical Medical Device, Biologics, and SaMD... ...conversation with our group's Senior Leader.Once all interviews are...SeniorMedical deviceWork at officeLocal areaRemote workWork from home3 days per week- The Senior Quality Engineer will provide quality engineering leadership and technical support within a regulated medical device manufacturing environment, with a strong focus on manufacturing... ...quality systems comply with FDA, ISO 13485, MDD/MDR, and applicable customer...SeniorMedical device
- ...System for its US sites. This role entails managing quality initiatives, defining performance metrics, and ensuring compliance with ISO 13485 and FDA GMP standards. The ideal candidate should have a Bachelor's degree along with at least 7 years of experience in quality...Senior
- ...client is seeking an experienced Senior Microbiologist to provide... ...support for contract manufactured devices, acquisition activities, new... .... Preferred Qualifications: Medical device industry experience... ...Familiarity with FDA regulations, ISO 13485, and other applicable global...SeniorMedical deviceContract work
- ...sponsorship available) About the Role As a Senior Supplier Engineer with Boston... ...5 years of technical experience in medical device development Experience with design... ...controls per 21 CFR 820 and MDR Auditor experience with ISO 13485 or similar quality systems Strong...SeniorMedical device3 days per week
- ...-04468 Job Description: The Senior Regulatory Affairs Manager will... ...and launch of innovative medical devices. Responsibilities: Prepare,... ...including FDA regulations and ISO standards. Provide regulatory... ...regulations, 21 CFR Part 820, ISO 13485, and other applicable...SeniorMedical device
$94k - $150k
...Senior Regulatory Affairs SpecialistThe Senior Regulatory Affairs Specialist for Ultrasound... ...Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.... ...regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable...SeniorMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$170k
Real is seeking a Senior/Principal Electrical Engineer to join a growing medical device organization in the Northeast Twin Cities Metro. The role focuses on verification... ...s in Electrical Engineering with 5+ years of experience, has FDA/ISO environment #J-18808-Ljbffr RealSeniorMedical device$160k - $180k
...Job Description Title : Senior Manager of Quality and Regulatory Location... ...0 - $180,000 + Bonus Industry: Medical Device and Healthcare Technology ---... ...regulatory standards, including FDA QSR, ISO 13485, and EU MDR, with emphasis on regulatory...SeniorMedical devicePermanent employmentContract workWorldwideFlexible hours- ...addressing the most critical challenges in the medical device industry. Patient care is at the heart... ...to delivering on that commitment.As a Senior Product Complaint Analyst, you will be... ..., including 21 CFR Part 820, EU MDR, MDSAP and ISO 13485. By leveraging data-driven insights...SeniorMedical deviceHourly payWork at officeLocal areaWorldwideRelocationRelocation packageShift work3 days per week
$75.3k - $150.7k
...Employees can qualify for free medical coverage in our Health... ...with their lives.As a Senior Engineer, you will be... ...for complex medical devices.Who We WantCritical... ...regulators such as FDA and ISO as it relates to design... ..., IEC 60601, GMP, ISO 13485, and ISO 14971.Prior medical...SeniorMedical deviceFor contractorsShift work- ...WHO WE ARE We are a growing medical device company developing... ...OPPORTUNITY We are seeking a Senior Design Assurance Engineer... ...documentation in accordance with ISO 14971 , including risk... ...environments and applying FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR...SeniorMedical deviceLocal areaFlexible hours
- ...Job Title: Senior Process Engineer Reports To: Director... ...processes within a regulated medical device environment. This role partners... ...maintain compliance with FDA and ISO requirements. Lead cross... ...System requirements and ISO 13485. ~ Experience with root-...SeniorMedical deviceFull timeWork at office
$92k - $138k
...first — developing innovative medical technologies that improve... ...are looking for a passionate Senior Regulatory Affairs Specialist... ...and changes to existing devices and documentation. Support of... ...guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory...SeniorMedical deviceFull timeH1bLocal areaImmediate startWorldwideFlexible hours- Senior Design Assurance EngineerThe Sr. Design Assurance Engineer supports... ...responsibility is supporting medical device software development in compliance with IEC 62304 and ISO 14971, while also contributing... ...2304, ISO 14971, FDA QSR, ISO 13485, and other applicable...SeniorMedical device
- ...member of the Quality team, the Senior Director Quality will be... ...Quality programs across the medical device lifecycle. This position ensures... ...management processes consistent with ISO 14971 requirements. Monitor... ...System Regulation (QSR), ISO 13485, and other applicable...SeniorMedical deviceFlexible hours
- Tactile Medical in Minneapolis, MN is seeking a Senior Firmware Engineer to design, develop, and maintain embedded software... ...for regulated at-home medical devices. You will lead firmware features,... ...and regulatory standards (IEC 62304, ISO 14971) including FDA 510(k). #J-18...SeniorMedical device
- Senior Quality Engineer (CAPA / QMS Focus)Location: Twin Cities, MNFull-time | OnsitePosition... ...for clinical-stage or Class II/III medical devices (PMA experience a plus).Key... ...compliance with applicable standards (e.g., ISO 9001, ISO 13485, AS9100, or industry-specific...SeniorMedical device
$80k - $200k
...Consulting 5+ years of experience in Complaints Management for Medical Device Strong understanding of FDA, EU MDR/IVDR requirements and... ..., Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 1...SeniorMedical deviceWork at officeLocal areaWork from homeFlexible hours- Job description: Sr SW Quality Assurance Engineer, medical devices, remoteThis role both actively participates in the development of product... ....Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all...SeniorMedical deviceRemote work
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