- Merck & Co. (Rahway, NJ)
- … medical devices and combination products globally.- Experience in design controls, device risk management, medical device , complex combination product ... are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product needs for commercial products-… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination ... timely delivery of project milestones Preferred experience & skills:- In-depth knowledge of medical device CMC landscape including knowledge of ISO standards, EU… more
- Novo Nordisk Inc. (Durham, NC)
- …years of validation related discipline experience in pharmaceutical or medical device industry required Experience in quality concepts including technical & ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...life-changing careers, and the opportunity to help improve the quality of life for millions of people around the… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU … more
- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical ...with 9+ years of experience, preferably in areas of medical devices, engineering, or quality assurance.Strong knowledge… more
- Aequor (Thousand Oaks, CA)
- … quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation according to company ... guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equivalent experience from any of these industries: Pharmaceuticals, biologics, Medical Device , Vaccines, Diagnostics, Generics/ Consumer productsDemonstrated ... around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the… more
- Cepheid (Miami, FL)
- …of the job include:Bachelor's degree in science with 14+ years of clinical quality /GCP experience within the device industry OR Master's degree in science ... with 12+ years of clinical quality /GCP experience within the device industryKnowledge of...offer comprehensive package of benefits including paid time off, medical /dental/vision insurance and 401(k) to eligible employees.Note: No amount… more
- Aequor (Thousand Oaks, CA)
- …improvements for ICSR medical review Conduct reportability assessment for medical device associated events and/or product complaint associated events, and ... of autolabel tool updates (if applicable) Support and lead Quality Assurance of ICSR medical review (if applicable) Support and lead activities for the… more
- Beckman Coulter Life Sciences (Miami, FL)
- …required.BS+7 or MS+4 years' experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), ... about the Danaher Business System which makes everything possible.The Staff Quality Assurance Engineer or Scientist is responsible for facilitating application of… more
- Cepheid (Miami, FL)
- …(IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities ... about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent ... about the Danaher Business System which makes everything possible.The Senior Supplier Quality Engineer for Cytiva is responsible to manage supplier defects, be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, ... advanced analytical tools and assays. Clinical data management experience in a medical device , pharmaceutical company, or similar environment (eg, CRO);… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Repligen (Rancho Dominguez, CA)
- …GED, or equivalent required.0 - 1 years of production/manufacturing with medical device assembly experience preferredPhysical Requirements: Regularly required to ... finished good specifications are met. This role is responsible for ensuring quality is built in performing fiber bundling, filter potting, filter welding, fitting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database and data validation programming and/or related work experience in a medical device , biotech, or pharmaceutical company, or similar environment (eg, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of relevant experience preferredData management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required 4+ years of proven ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Cytiva (Miami, FL)
- …control testing, and sterility assurance processes in a highly regulated medical device environment.This role involves conducting laboratory analyses, ... 14644, sterility processes, and cGMP (current Good Manufacturing Practices) in medical device product manufacturing.Experience with Water, Endotoxin, Bioburden,… more
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