- 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, ... Device Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management Systems (QMS). + 3+ years of technical program… more
- Caldera Medical (Westlake Village, CA)
- …engineering, Life Sciences, or a related technical field. - 10+ years of experience in medical device Quality , including leadership roles. * Minimum of 5 ... Quality Management System (QMS), ensuring alignment with global medical device regulations such as ISO 13485,...Medical is a growth stage medical device company dedicated to improving the quality … more
- Terumo Neuro (Aliso Viejo, CA)
- …validation and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven experience in ... quality engineering projects to support the manufacturing of medical devices. Work with Manufacturing and R&D in leading...design verification, and design validation. 2. Strong knowledge of medical device design control process. 3. Ability… more
- ManpowerGroup (Fremont, CA)
- …degree in engineering or a related field with a minimum of 7 years of medical device quality assurance experience. + In-depth knowledge of quality ... a leader in the healthcare industry, is seeking a Quality Engineer III to join their team. As a...with cross-functional teams. **What's in it for me?** + Medical , Dental, Vision, 401k with Match + Weekly pay… more
- Gilead Sciences, Inc. (La Verne, CA)
- …provides comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system ... + Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations + Participate in the… more
- Edwards Lifesciences (Sacramento, CA)
- …in a related field * Eight years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (eg cardiac care ... understanding of FDA's Quality System Regulation * Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD… more
- AbbVie (Pleasanton, CA)
- …have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year of ... (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes & GMP; & + working… more
- 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
- 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
- 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
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