- Merck & Co. (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on… more
- Merck & Co. (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new… more
- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... (Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong understanding… more
- Philips (New Kensington, PA)
- …+ You have a minimum of 5+ years' experience within FDA regulated medical device Quality environments, with a focus on CAPA reviews, investigations, ... The Senior Quality Engineer-CAPA will play a critical role within...opportunities for improvement. + You have detailed knowledge of medical device regulations, requirements, and standards, such… more
- Abbott (Irving, TX)
- …that drive results and continuous improvement. + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO guidelines ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- J&J Family of Companies (Santa Clara, CA)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... Must not be debarred by FDA for work in any Medical Device business. + Establishes and maintains relationships with customers, hospitals, and physicians.… more
- J&J Family of Companies (Albany, NY)
- …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
- Cedars-Sinai (Los Angeles, CA)
- …years of 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. 4. Delivery:...Team** Cedars-Sinai is one of the largest nonprofit academic medical centers in the US, with 886 licensed beds,… more
- Philips (New Kensington, PA)
- …You have a minimum of 7+ years' experience in Post Market Quality within FDA regulated medical device environments, with a focus on Complaint Handling ... and resolving complaints and upholding high standards of service quality and customer satisfaction. **Your role:** + Manages a...within the team. + You have detailed knowledge of medical device regulations, requirements, and standards, such… more
- Sanofi Group (Framingham, MA)
- …years) with a minimum of 15 years relevant experience in the pharmaceutical, biotech, medical device , or related industries. + Extensive knowledge of Quality ... **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA... Quality Council to facilitate sharing of US FDA inspection findings and best practices across entities, M&S… more
- Hologic (Newark, DE)
- …to commercialization. + **Regulatory Standards:** Familiarity with ISO and FDA quality systems regulations and medical device design and development ... Experience:** + Experienced with ISO and FDA quality systems regulations. + Prior experience in medical... quality systems regulations. + Prior experience in medical device design and development cycles. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Wolters Kluwer (Indianapolis, IN)
- …to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA Class II medical device experience, focused on software as a medical ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities… more
- AbbVie (Pleasanton, CA)
- …discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, ... GD&T + performing daily assigned tasks in compliance with FDA 's Quality System Regulation (QSR), ISO 13485,...MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes… 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
- Merck (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on… more
- Merck (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... description** This position will be responsible for leading and implementing medical device and combination product design controls for both new products and… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …Platforms + A minimum of 5 years' experience in managing FDA and ISO Medical Device Quality and facility inspections. + Proven record of relating ... and audit support functions. + Provide leadership in the understanding of medical device regulations to other disciplines. + Communicate effectively at… more
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