- Abbott (Alameda, CA)
- …History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Develops and ... Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a ... global team focused on R&D Quality . This global role includes direct reports in the...submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader… more
- Cordis (Irvine, CA)
- …measures at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements. + Process Improvement: ... solutions that address unmet and critical medical needs. The **Principal Manufacturing Quality Engineer** will be responsible for ensuring that our medical devices… more
- Bayer (Berkeley, CA)
- …customers as well as internal auditors/inspectors; + Ensures conformance to all regulatory requirements, including those of the FDA and various international ... minds to make a real difference, there's only one choice.** ** Quality Control Testing Microbiology Lead** Provides leadership, technical oversight and coaching… more
- Kelly Services (Lodi, CA)
- …in a manufacturing environment and familiarity with (1) ISO standards, (2) applicable regulatory requirements (CE/ FDA /QSR), and (3) GDP_** **.** **Pay Rate:** + ... Kelly(R) Science & Clinical is seeking a ** Quality Assurance Specialist I** for **12mo- contract position...+ Must be familiar with ISO standards and applicable regulatory requirements (CE/ FDA /QSR) and GDP. + Ability… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …Angeles Manufacturing Facility. The role is essential in ensuring that all quality -related activities meet regulatory standards and uphold Takeda's commitment to ... **About the role** This position holds ultimate responsibility for the overall Quality Assurance of Site Teardown and Fractionation Operations at Takeda's Los… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- **Job Description Summary** The Director, Quality Engineering - WW IPD is responsible for developing and leading the global Design Center Quality function for ... are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer expectations for safety and effectiveness. Reporting… more
- Abbott (Pleasanton, CA)
- …and Control Plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, ... work experience + Engineering experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA ,...of Quality tools/methodologies + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 + Solid… more
- US Tech Solutions (San Bruno, CA)
- …and corporate requirements. ** Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations… more
- Abbott (Pleasanton, CA)
- …Core Team Member) + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... + 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA ,...of Quality tools/methodologies + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 + Project… more