- ThermoFisher Scientific (San Francisco, CA)
- …**Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality , regulatory and ... Systems aligning with Regulatory and Corporate Standards. Guide team to foster quality culture, compliance , and improvement. Lead team responsible for Document… more
- Oura (San Francisco, CA)
- …product development, approval, and lifecycle management for all regulated features. + Ensure compliance with FDA , CE (MDR), and other relevant global regulatory ... We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping...wearables strongly preferred. + Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …for establishing standards and implementing procedures to ensure that the business units quality management and compliance program are effective and efficient in ... compliance and mitigating risks, The performance of the Quality Systems and Risks will be reported periodically to...Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment +… more
- Abbott (Santa Clara, CA)
- …software, cybersecurity, telehealth, etc.) have targeted mitigations to align with FDA expectations, ensuring high- quality submissions and predictability for ... requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory activities and… more
- US Foods (Hawthorne, CA)
- …Join Our Community of Food People! BASIC PURPOSE Improve product quality and consistency by conducting checks at receiving, processing and shipping. ... activities in the plant. Monitor implementation all Food safety, Regulatory and Quality programs within the assigned area of responsibility **Stock Yards -… more
- Sysco (Fremont, CA)
- …**Education** + Formal job training in TQM principles, SPC, HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and sensory ... **JOB SUMMARY** Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and… more
- Actalent (Vista, CA)
- …aspects of the company. This includes the development and maintenance of the Quality Management System, obtaining FDA and ISO certifications, and product ... Quality System. + Conduct internal audits to ensure compliance . + Receive, review, and respond to customer product...quality supplements, annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …the interface between Worldwide IPD and MMS forDesign quality assurance, Quality Management System (QMS) alignment and compliance , and Inspection and audit ... **Job Description Summary** The Director, Quality Engineering - WW IPD is responsible for...that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards and meet… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- … on the Shop Floor, all of which are critical to maintaining compliance and driving operational efficiency. Beyond quality oversight, the role contributes ... Collaborate closely with Manufacturing and Engineering teams to support Quality decisions on the shop floor, ensuring compliance...management role with direct reports + Deep knowledge of FDA , EMA, CFDA, and PDA regulations, including Good Data… more
- J&J Family of Companies (Santa Clara, CA)
- …**Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** ... Description:** Johnson & Johnson is hiring for a **Sr. Quality Engineer - Shockwave Medica** l to join our...with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21… more