Quality Systems Lead: ISO 13485 for Medical Devices
RSA LLC
RSA LLC is seeking a Quality Systems Specialist based in Woodinville, Washington. This role involves ensuring successful implementation of ISO 13485 quality system policies and procedures, conducting audits, and engaging with vendors to uphold quality standards. The ideal candidate will possess a Bachelor’s degree, 2+ years of experience in a quality management setting, and strong communication and project management abilities. Join a team dedicated to making a positive impact in medical device services. #J-18808-Ljbffr RSA LLC
- ...Job Description Position Title: Quality Systems Specialist Reports To: Director of... ...Solutech, our mission is to ensure critical medical devices are always available to support the... ...the successful implementation of ISO 13485 certified quality management system policies...QualityMedical deviceDay shift
$149.06k - $184.72k
...Overview Verathon is a global medical device company focused on... ...trusted partner, delivering high-quality products that endure over... ...laryngoscopy & bronchoscopy systems effectively address unmet needs... ...standards such as ISO 13485 and ISO 14971 is preferred...QualityMedical deviceFull time$104.03k - $155.84k
...Cities, Uncrewed Aircraft Systems (UAS), and Airspace > Management... ...across production, quality, supply chain, and... ...manufacturing, industrial, aerospace, medical device, or other regulated... ...industry standards such as ISO 9001, AS9100, or ISO 13485 is a plus. * Strong...QualityMedical deviceFull timeTemporary workWork at officeFlexible hours- ...FDA Audit Readiness Lead Lead FDA audit and inspection readiness... ...effectiveness, investigation quality, risk assessments, and HHE... .... Review and strengthen CAPA systems to ensure regulatory... ...regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare...QualityMedical device
$69 - $115 per hour
...Senior Fuel Handing Systems Design Engineer Position... ...to coordinate and lead a design team's effort... ...Experience working to quality standards on design activities... ...such as ASME NQA-1 or ISO 9001. Strong... ...to AI, Clean Tech, Medical Devices, and Connected Technologies...QualityMedical devicePermanent employmentContract workRemote work- ...Summary Progressive Quality Engineering experience in the Medical Device industry with hands-on... ...teams. Responsible for leading design control, risk... ...changes to the Quality System based on new regulations... ...implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601...QualityMedical deviceWork at office
- ...Join Stryker as a Senior Quality Assurance Engineer in Redmond... ...ensure that life-saving medical devices meet the highest standards... ...and key business functions. Lead internal and supplier... ...manufacturing and quality system standards (e.g., ISO 13485, Good Manufacturing Practice...QualityMedical deviceWorldwide
- ...activities for ultrasound systems. This role is critical... ...risk assessments per ISO 14971. Maintain and... ...820. EU MDR. ISO 13485. ~ Support audits... ...R&D / Engineering. Quality & Regulatory Affairs.... ...of experience in: ~ Medical device risk management & CAPA....QualityMedical device
- ...Design Assurance / Quality Assurance Engineer... ...knowledge of medical device product development... ...standards including ISO 14971, IEC 62304,... ...(21 CFR 820), ISO 13485, and related product... ...standards. Lead and facilitate design... ...integration testing, and system testing. Review...QualityMedical device
$24.03 - $31.75 per hour
...Quality Inspector III Location US-WA-Bothell ID... ...Verathon is a global medical device company focused on supporting... ...laryngoscopy & bronchoscopy systems effectively address unmet needs... ...software * Familiarity with ISO 13485 and FDA cGMP regulations desirable...QualityMedical deviceFull time- ...in our product PLM system Windchill. You review... ...with Development leads, packaging engineers... ...process a compliant Device History File (DHF) and... ...Regulated Industry (medical devices desirable,... ...with knowledge of FDA Quality System Regulations, and ISO 13485) 7. Proficient in...QualityMedical deviceWork at officeShift workNight shift
- ...Bruker Daltonics in Bothell, WA, is seeking a Quality Control Inspector to oversee the quality... ...compliance with quality management systems. The ideal candidate will have a Bachelor... ...regulated environments, and a strong working knowledge of ISO standards. #J-18808-Ljbffr...QualityMedical device
- ...Serves as a liaison between Medical Affairs, Clinical... ...Reports. Conduct Periodic Quality Review Board Meetings... ...-MDR regulated Medical Device environments with a... ...Parts 803, 806, and 820, ISO 13485, ISO 14971, European... ...Quality Management Systems (QMS). Regulatory Requirements...QualityMedical device
- ...Position Title: Principal Systems Engineer Work Location: Bellevue... ...with a deep understanding of medical device regulations and best... ...system integration points and lead the team in integration planning... ...medical device regulations, quality systems, and data privacy regulations...QualityMedical deviceWork at office
- ...Lead Ultrasound Engineer We are seeking ambitious... ...to improve image quality, including advanced matrix... ...documentation that complies with medical device regulations, standards, and our quality system Collaborate with... ...and guidance (e.g., ISO 13485, ISO 14971, IEC 62304,...QualityMedical device
- ...Quality Acceptance Inspector (Woodinville, WA) Job Description Summary QA Acceptance... ...of regulatory/quality management system requirements related to incoming inspection... .../or sorting of suspect materials for medical devices, consumer goods, or other products within...QualityMedical device
- ...Observability Build and own large-scale data pipelines and observability systems that power metrics, logging, and real-time insights across... ..., improving monitoring and alerting, and ensuring data quality and system visibility at scale. Ideal candidates have strong distributed...Quality
$132.98k - $199.47k
...Cybersecurity Engineer - Aircraft Power Systems Position Description:... ...client's reputation as a leading expert in aircraft... ...and peer reviews. Assure the quality of designs through diligent... ...Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies....QualityMedical deviceRemote workWork from homeFlexible hours2 days per week3 days per week$84k - $110k
...external and internal cardiac medical device markets. The company was... ...Kestra's solutions combine high quality and technical performance... ...process conformance to FDA QSR, ISO 13485, and EU MDR requirements.... ...for oversight of system quality, post-market surveillance...QualityMedical deviceContract workWork experience placementWork at officeLocal areaWork visa- Protingent is seeking a contract V&V I&C Engineer to lead the planning and execution of digital I&C V&V for reactor systems. The ideal candidate will have a B.S. or higher... ...V&V schedules, ensuring compliance with quality standards, and providing oversight of supplier...QualityRemote jobContract work
$41.5k - $66k
...As one of the world’s leading analytical instrumentation... ...development. All our systems and instruments are... ...successfully enhancing quality of life. We have been... ...Bruker Spatial Biology, ISO 13485 and ISO 9001 Quality... ...environment i.e. medical device/ biotechnology/ aerospace...QualityMedical deviceFull timeTemporary work$80 - $145 per hour
...Title: Manufacturing Test Architect - Systems & Infrastructure Position Description... ...backend systems that ensure hardware quality at a global scale. System Architecture... ...IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide...QualityMedical deviceContract workShift work- Job Title:Design Quality Engineer - Medical Devices Location:Bothell, WA Work Mode:Onsite Client:Tata Elxsi |... ...Design Control activities as per FDA and ISO standards Participate in design... ...Familiarity with:21 CFR Part 820 ISO 13485 ISO 14971 EU MDR and other medical device...QualityMedical deviceContract work
$115k - $158k
...EH&S Product Reg. Comp. Manager Aesthetic Medical Device (WA) Job Location: Bothell, Washington, USA... ...PLM and EH&S compliance data management systems Experience working within a regulated quality system environment (ISO 13485 preferred). Strong documentation, regulatory...QualityMedical device$155.55k - $221.12k
...Verathon is a global medical device company focused on supporting... ..., delivering high-quality products that endure... ...& bronchoscopy systems effectively address unmet... ...Manager is responsible for leading systems software and... ...Working knowledge of ISO 13485, ISO 14971 and IEC 62...QualityMedical deviceFull timeTemporary work- React Health Holdings, LLC is seeking a Quality Inspector II to join our team in Woodinville... ...Receiving Inspection and quality control systems. Key responsibilities include performing... ...records. Join us in providing quality medical equipment to support caregivers and patients...QualityMedical deviceFull time
$117.2k - $313.7k
...large-scale data pipelines and observability systems that power metrics, logging, and real-... ...and alerting, and ensuring data quality and system visibility at scale. Ideal candidates... ...live well including: time off programs, medical, dental, vision, mental health support, paid...Quality$102.78k - $131.78k
...Senior IT Systems and Support Technician (Life Sciences... ...experienced technical lead and key contributor to... ...Ensure complete and high-quality documentation of... ...macOS workstations, mobile devices (iOS and Android), and... ...industries (biotech, pharma, medical device) strongly...QualityMedical device- ...Bothell, Washington seeks a Sr. Specialist in Electronic Quality Management Systems. You will administer the MasterControl eQMS, ensuring compliance... ...bonuses, and comprehensive employee benefits including medical insurance and a 401(k) plan. #J-18808-Ljbffr Lyell...Quality
$28 - $34 per hour
...responsible for ensuring high-quality materials are available... ...part master and vendor lead time data in the ERP system. Purchasing: Obtain... ...of instrumentation and/or medical devices. Knowledge and experience... ...quality system environment (ISO 13485, FDA cGMP/QSR). Prior experience...QualityMedical deviceHourly payTemporary workLocal areaRemote workMonday to Friday
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