- Cedars-Sinai (Los Angeles, CA)
- …10 Years' experience using 3D model software preferred + Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO ... and full end-to-end integration tests, when it applies; Supports quality insurance effort to gain user acceptance. + Delivery:...Team** Cedars-Sinai is one of the largest nonprofit academic medical centers in the US, with 886 licensed beds,… more
- Pentax Medical (Redwood City, CA)
- … Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Medical Device Assembler- Catheter Why ... JOIN Us? We are an established medical device leader that is preparing for...office (ie Word, Excel). . Previous experience working in quality management systems, functioning within FDA regulations.… more
- Pentax Medical (Redwood City, CA)
- …Position Opening: Quality Assurance Technician Why JOIN Us? We are an established medical device leader that is preparing for high growth. This means that ... of NCRS and that the final product meets all FDA requirements. About the Quality Assurance Technician:...+ Minimum 5 years QA or QC experience in medical device industry + Proficient with standard… more
- Terumo Medical Corporation (Somerset, NJ)
- …required by FDA , Canadian, European and International regulations related to medical device manufacturers and will maintain all complaint and complaint ... TMC Quality Management Leadership Team. 2. Oversee medical device complaint processing in compliance with...in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part… more
- Eurofins (Boston, MA)
- …Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management. + Foster a culture of ... vision and team to support our clients in the medical device industry across their product innovation,...FDA with a strong focus on regulatory affairs, quality , and compliance. + Demonstrated expertise in consulting services,… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA ,... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Sutter Health (West Sacramento, CA)
- …in Northern California within the Sutter Health footprint. Responsible for Cyber Security, Medical Device Vulnerability, Medical Device Integration, and ... comprehensive action plans to address gaps and enable successful execution of medical device integration and technology advancement including testing, release… more
- Mayo Clinic (Rochester, MN)
- …will have interest/exposure to areas of device safety, quality management, and FDA medical device regulation. The candidate must be able to work ... a highly qualified graduate student in engineering or a quality related field to assist our quality engineer...in medical device development. They… more
- Merck (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... injection. This position will be responsible for leading and implementing medical device and combination product design controls and risk management activities… more
- Integra LifeSciences (Sparks, NV)
- …meet compliance requirements. + Demonstrated knowledge of FDA regulations, applicable medical device / quality system ISO standards, CMDR, EUMDR and other ... headway to help improve outcomes. SUMMARY DESCRIPTION As the Quality Engineer for a medical device manufacturer, this position is primarily responsible… more
- Teleflex (Chelmsford, MA)
- Medical Device Assembler **Date:** Nov 20, 2024... FDA guidelines in the effort to manufacture high- quality medical devices at all times. * Perform ... a difference in patients' lives. **Position Summary** As a Medical Device Assembler, you will join a...you will join a dynamic team dedicated to manufacturing high- quality medical equipment that directly impacts the… more
- Sanofi Group (Bridgewater, NJ)
- …will be responsible to lead the design, development, and implementation of connected medical device technologies and ensuring they meet the specific needs of ... representatives from the core device platforms and device manufacturing sites, Digital, Global Quality , GRA...work experience in the area of connected & digital medical device technologies or equivalent. + Working… more
- University of Virginia (Charlottesville, VA)
- …cardiac device programming for surgical patients. + Help coordinate cardiac device FDA recalls and advisories, working with risk management on patient ... The Cardiac Device Specialist at UVA Health University Medical...small team of nurses to ensure the delivery of high- quality , patient-centered care. Sign-on bonus, up to $20,000, may… more
- Philips (Cambridge, MA)
- …robotics experience is a plus. + You have broad experience in healthcare/ medical device or other safety critical/regulated areas (automotive, aviation, military, ... medical products and have supported regulatory submission for FDA 's 510K, IDE, DeNovo or PMA processes. Medical...won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- Fujifilm (Twinsburg, OH)
- … components. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard ... please visit_ _healthcaresolutions-us.fujifilm.com_ _._ **External US** **Job Title** **: Medical Device Repair Technician** **Job purpose** This position… more
- Lilly (Concord, NC)
- …technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and ... Supervisor will have responsibility of supporting start-up activities to bring the Device Assembly and Packaging (DAP) area into service. This will include… more
- Adecco US, Inc. (Mansfield, MA)
- Adecco is searching for a medical device assembler in Mansfield! This is a temp to perm role on 2nd shift. **Hours:** 2nd Shift **Pay:** $20.35 per hour **Job ... and other steps along the production line of various medical devices as required by clients. Adherence to Good... devices. * Knowledge and experience with GMP, ISO, FDA , and quality standards * Experience in… more
- Kelly Services (Bothell, WA)
- Kelly Services is seeking qualified 1st & 2nd shift candidates for an Electronic Medical Device Assembly role! This is a unique, _temp to hire_ opportunity, for ... our clients in Bothell, WA. **,** manufacturing cutting edge medical devices! Two years of assembly experience in an...environment is required. + Experience working within a rigorous, quality control environment such as FDA cGMP/QSR… more
- Adecco US, Inc. (Southington, CT)
- Adecco is assisting a customer in Southington in need of Medical Device Assemblers. Daytime, Evening and Overnight shifts available (weekend OT as needed). The ... be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes… more
- Fujifilm (Twinsburg, OH)
- …business. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard ... needs of healthcare across prevention, diagnosis, and treatment. Fujifilm's medical imaging portfolio includes solutions for digital radiography, mammography,… more
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