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Job alert Jobs 21 - 30 of 462

Senior Quality Specialist

Kelly Science, Engineering, Technology & Telecom  –  Sunnyvale, CA, 94087
... Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities in accordance with FDA and ISO regulations. This position is part of the Product ... - Jun 18

Director, Quality Assurance Operations

Adicet Bio, Inc.  –  Redwood City, CA
... The candidate will be reporting to VP of Quality Assurance and is responsible for the strategic development and management of QA operations to support CMC operations and clinical activities in compliance with FDA, ICH, EMA regulations, guidances, ... - Jun 22

Junior R&D Engineer

Meditrina Inc  –  San Jose, CA
... Duties and Responsibilities: · Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA QS Regulation, ISO, MDD, CE Mark, and Canadian Medical Devices Regulations. · Responsible for ... - Jun 18

Senior R&D Engineer

Meditrina Inc  –  San Jose, CA
... Duties and Responsibilities: · Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA QS Regulation, ISO, MDD, CE Mark, and Canadian Medical Devices Regulations. · Responsible for ... - Jun 18

Staff Quality Assurance Engineer

Telos Health, Inc.  –  Campbell, CA, 95008
... Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations Experience with Quality Control (IQC, In process ... - Jun 11

Staff Scientist, Product Development

Yoh, A Day & Zimmermann Company  –  San Jose, CA
... Ensure compliance with regulatory standards (e.g., FDA, ISO) and comply with biohazard safety standards. Participate in product risk assessment, technical design reviews and critically evaluate design and implementation plans. Summarize findings and ... - Jun 18

Regulatory Affairs Specialist

GForce Life Sciences  –  Santa Clara, CA, 95053
... of experience in regulatory affairs Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA) or with EU and other international medical device regulation submissions Hands-on experience with 510k submissions, or ... - Jun 17

VP, Analytical Development and Quality

Bayside Solutions  –  Santa Clara, CA, 95053
... and working experience in innovative drug development and manufacturing concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements Extensive working experience with management and oversight of the analytical ... - Jun 18

Sr. Manager QC

Yoh, A Day & Zimmermann Company  –  San Jose, CA
... Develops and implements departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, CLIA, OSHA, etc.). Ensures department adherence to established procedures. 4. Ensures timeliness and efficiency of product and material ... - Jun 20

Senior Director, Drug Product

Bayside Solutions  –  Santa Clara, CA, 95053
... Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements Extensive experience in late-phase drug product development and ... - Jun 18
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