- Gilead Sciences, Inc. (Foster City, CA)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma industry. ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Action decision, as applicable. + Collaborates with leadership in Business Unit Quality , Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, ... other technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class… 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
- CTG (Woodland, CA)
- …**Description** The Quality Engineer II will develop and support all Quality Management System (QMS) and Regulatory Affairs (RA) activities in alignment ... goals and metrics. This role is responsible for new product setup, quality project management, and ensuring regulatory compliance for serum products. The… more
- AbbVie (Irvine, CA)
- …*Ensures that product is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. *Supplier ... + Technical knowledge in as many of the following areas as possible: Quality , Regulatory , Process Sciences, Manufacturing Operations. + Knowledge and familiarity… more
- Abbott (Pleasanton, CA)
- …peers understand quality system requirements and how they impact product quality and regulatory compliance. + Represents the division within Abbott through ... the audit results. + Analyze trends from various sources and proactively address regulatory , compliance, and quality issues. + Actively participate in FDA… more
- Cordis (Irvine, CA)
- …that address unmet and critical medical needs. **Responsibilities** The **Senior Engineer, Quality Manufacturing** , joining the Quality team, will be ... for ensuring that our medical devices meet the highest quality standards throughout the manufacturing process. You will be...ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory… more
- ThermoFisher Scientific (San Francisco, CA)
- …Investigations, Change Controls, CAPAs, Metrics & Trend Reports. Develop and implement Quality Systems aligning with Regulatory and Corporate Standards. Guide ... cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality , regulatory and production attitude with an appreciation for client service and the… more
- Hologic (San Diego, CA)
- …you will manage our supplier auditing program, ensuring that our suppliers adhere to rigorous regulatory and quality standards. You will lead and guide a team of ... from the auditing/assessment program. + **Issue Escalation:** Report any potential quality or regulatory issues to the Global Supplier Quality Sr.… more
- Philips (San Diego, CA)
- …scope typically smaller and less complex projects. + Demonstrates basic understanding of Regulatory 's role in the Quality System with basic awareness of product ... Agency changes. **You're the right fit if:** + Experience in regulatory affairs, quality compliance, product development or equivalent in the medical device… more