- Hologic (Newark, DE)
- …cross functional projects with global reach. + Experienced with ISO and FDA quality systems regulations and medical device design and development cycles. ... Supplier Quality Engineer 2 Newark, DE, United States There...Metals) + 2 or more years of experience in medical device manufacturing or related industry. +… more
- 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
- Merck (Columbus, OH)
- **Job Description** The Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality ... combination products. This role ensures the highest standards of device quality throughout the product lifecycle, from...or a related field within the pharmaceutical, biotechnology, or medical device industries. + Demonstrated expertise in… 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
- 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
- Merck (Wilson, NC)
- …products. + Experience with injection molding and working with medical device suppliers. + Experience leading Quality Management System gap assessments ... MDCP Operations Lead position will serve as the primary medical device and combination product (MDCP) point...liaison between the site and global MDCP teams (Technical, Quality , etc.), providing hands-on shop floor perspective and advocating… 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
- Vera Therapeutics (Brisbane, CA)
- …drug products is a plus. * In-depth knowledge of current FDA and EU medical device regulations and quality systems. * Experience with human factors ... will possess a deep understanding of drug delivery systems, medical device regulations, and a proven track...* Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations (eg, MDR) for medical… 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
- ManpowerGroup (South San Francisco, CA)
- …Medical Device manufacturing/ Quality experience + Demonstrated knowledge in medical device regulations ( FDA , ISO, MDSAP, IVDR) + Advanced computer ... auditing activities in South San Fran, CA. **Job Title: Medical Device Senior QA Auditor** **Location: South...reports + Actively supports regulatory inspections and preparing for FDA audits + Identifies and drives process improvements +… more
- Merck (Columbus, OH)
- …**Position Title** -Director/ Principal Scientist, Regulatory Compliance **Department** - Device Quality & Regulatory **Brief Description of Position-** ... This position will be part of the Device Quality & Regulatory Team within Global...to ensure regulatory compliance for the company's portfolio of medical devices and medical device … more
- Teleflex (Chelmsford, MA)
- Medical Device Assembler - 2nd Shift **Date:**... FDA guidelines in an 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
- Takeda Pharmaceuticals (Boston, MA)
- …and meetings with global health authorities + Reviews and approves medical device development design control documentation, including technology transfer ... a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international experience is a… 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
- 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
- BD (Becton, Dickinson and Company) (Woburn, MA)
- …and safety standards (OSHA, NFPA, IBC, NEC codes, etc.) + Understanding of medical device manufacturing as it relates to FDA , GMP's and ISO + Ability to ... accordance and compliant to requisite regulating bodies to include: FDA , OSHA, EPA, MA DEP (Mass Department of Environmental...janitorial, plumbing, electrical, HVAC, etc) + Minimum 1 year medical device experience in facilities or engineering… 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
- 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