- Gilead Sciences, Inc. (Foster City, CA)
- …and review/approve Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance: engage/liaise with ... seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the...medical device product engineering, development, and quality teams. + Facilitate Analytical Strategy (stability strategy, specifications,… more
- GRAIL (Durham, NC)
- … quality management system (QMS). The primary focus is on supporting GRAIL's Quality Management System for medical device processes, with consideration ... clinical laboratory (high complexity CLIA/CAP environment) or related (eg, IVD medical device , pharma, etc.) quality management system. + Experience working… more
- Actalent (Huntington Beach, CA)
- …pFMEAs, MVP, IQ / OQ / PQ / PPQ, TMVs is desirable. - An understanding of medical device quality regulations, practices and quality standards, such as ... including skills in product and process development, Manufacturing Engineering, preferably in the medical device industry - A strong working knowledge of process… more
- Kelly Services (Rochester, NY)
- …**_Preference with Chemistry background._** + Minimum 4 years in medical device or pharmaceutical industry in Quality , R&D, Engineering or Laboratory ... + Previous Compliant management, complaint review and corrective action. + Quality experience in medical device or pharma industry. + Knowledge of structured… more
- Cook Medical (Bloomington, IN)
- …is required. + Knowledge of CE marking standards, preferred. + Knowledge of medical device quality standards/practices or similar regulated industry. + ... projects within specific timelines and meeting performance expectations. + Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO… more
- Actalent (Minneapolis, MN)
- …algorithms to enhance image quality . + Ensure adherence to stringent medical device quality systems through meticulous verification, extensive ... endoscopes. This position requires a deep understanding of embedded systems engineering, medical device regulations, and the technical challenges associated with… more
- J&J Family of Companies (Santa Clara, CA)
- …while professionally representing the company. + Comply with all corporate compliance, FDA, medical device , quality standards and ethics. + Other duties ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
- J&J Family of Companies (Albany, NY)
- …while professionally representing the company. + Comply with all corporate compliance, FDA, medical device , quality standards and ethics. + Other duties ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
- Abbott (Alameda, CA)
- …experience + Minimum 3-5 years of Quality Assurance experience in the medical device , pharmaceutical or other quality managed industries **Preferred ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Actalent (Minneapolis, MN)
- …transmission through RF signals over coaxial cabling. + Ensure adherence to stringent medical device quality systems through verification, documentation, and ... in the design and validation of electromechanical systems. Essential Skills + Medical device engineering experience. + Expertise in electrical and mechanical… more
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