- Actalent (Lafayette, CO)
- …Quality Assurance and Compliance: Follow Quality System Practices and meet FDA , ISO, and European Medical Device standards and regulations, ... + Experience in the medical device industry. + Familiarity with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971,… more
- Actalent (Dallas, TX)
- …Validation testing, Medical device , Equipment validation, Engineering, Quality assurance, Iso 13485, Method validation, Fda , Equipment qualification, ... Top Skills Details Validation,Validation protocols,Pq,Oq,Iq,Gmp,Process validation,Validation testing, Medical device ,Equipment validation,Engineering, Quality assurance,Iso 13485,Method validation, Fda ,Equipment… more
- J&J Family of Companies (Fort Worth, TX)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's license. + Operate as a team and/or… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education and relevant experience. **Knowledge and Key Skills:** + Working knowledge of the FDA medical device quality system regulations and ... **Job Description Summary** The Sr. Quality System Specialist is accountable for support of...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- Actalent (Dallas, TX)
- …degree in engineering or equivalent work experience. + Knowledge of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and ... Medical Device Validation Engineer - Dallas... Medical Device Validation Engineer - Dallas The overall goal...device validation + Equipment validation + Engineering + Quality assurance + Method validation + FDA … 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
- 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
- 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
- Integra LifeSciences (Boston, MA)
- … Engineering/ Quality Compliance/ Quality Assurance experience in the Medical Device or similar FDA regulated industry. Integra LifeSciences is ... results of risk analysis. + Support as required the Quality Management Review Process. + Participate in FDA...of statistical sampling and analysis. + Working knowledge of medical device regulations (including FDA … 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
- 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
- Actalent (Elgin, IL)
- …corrective action. + Knowledge of FDA (cGMP), ISO 13485 Work Environment medical device manufacturing environment. Pay and Benefits The pay range for this ... Job Title: Complaint Specialist, Quality Exciting opening for a Complaint Specialist! In...+ 2-4+ years' experience in Complaint Handling in the medical device industry + Bachelor's degree preferred… more
- Merck (West Point, PA)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on… more
- Abbott (Santa Clara, CA)
- …and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to be located ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… 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
- System One (Lakewood, CO)
- …of Science degree in Engineering or computer science preferred + Strong in design quality for embedded medical device software or software development for ... SW development improvements in agile environments while complying with medical device regulations. + Anticipate roadblocks and...Requirements: + 8 years of experience, including 3-4 in medical devices ( quality for design and development… 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
- Aerotek (Irvine, CA)
- ** Medical Device Production Technician - 1st or 2nd Shift** **Job Description** This position is responsible for the production of high- quality medical ... and machinery. **Pay:** **1st shift: $22-26, 2+ years of medical device assembly.** **2nd shift: $24-28, 2+...Growth is forecasted with the product working to become FDA approved in the US next year. This opportunity… more
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