- Abbott (Temecula, CA)
- …effectiveness and maintaining compliance of the Quality System. (eg compliance with internal procedures and FDA , BSI regulations etc). + Interacts with ... new tools based on findings. + Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by… more
- Insight Global (San Diego, CA)
- …involves close collaboration with various teams to ensure the highest standards of quality and regulatory compliance for post market hemostasis products. Key ... principles in quality assessments for medical device components. ISO 13485 Compliance : Utilize ISO 13485 standards in quality management processes for… more
- Kelly Services (Carlsbad, CA)
- …regulatory best practice. + Collaborate and lead teams to drive sustained quality enhancements and global compliance . **Qualifications** + Bachelor's degree in ... Kelly(R) Science & Clinical is seeking a Lead Auditor, GMP Quality Systems for a direct hire opportunity with one of our clients, a commercial-stage biotechnology… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …utilization and optimization + **Global Systems:** Manage and optimize global Quality systems to ensure compliance , efficiency, and continuous improvement. ... **Job Summary** The Senior Director of Quality Strategy and Operations will be responsible for...and maintain data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (eg, FDA , EMA)… more
- Cordis (Irvine, CA)
- …therapy to the market by developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and ... actions. + Documentation: Maintain accurate and complete documentation of quality -related processes, inspections, and testing, ensuring compliance with… more
- Hologic (San Diego, CA)
- …circumstances. + Additional Responsibilities: + Leads additional projects/processes in support of compliance and quality requirements. + Serves as a mentor on ... cause analysis, and scientific problem-solving. + Experience with complaint investigation, CAPA, and quality systems ( FDA , ISO 13485, EU MDR). + Understanding of… more
- Stryker (Irvine, CA)
- …onboarding materials, documentation practices, and targeted training programs focused on compliance , quality culture, and process understanding. + Mentor and ... across systems, processes, and procedures, with an emphasis on integration, compliance , and cross-functional alignment. + Lead quality issue investigations… more
- Kelly Services (Anaheim, CA)
- …+ Monitor the complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with applicable local ... **Director of Quality and Regulatory Affairs** Kelly(R) Science & Clinical...as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while… more
- Kelly Services (Pleasanton, CA)
- …will be responsible for the development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good ... including preparing and managing site-specific documentation. + Establish and ensure compliance with GLP, GCLP, and applicable FDA regulatory standards.… more
- Actalent (Irvine, CA)
- Job Title: Design Quality Engineer Job Description We are seeking a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory ... This role is critical in ensuring the integrity and compliance of marketing claims associated with our medical devices....The ideal candidate will have a strong experience in quality systems within the medical device industry and a… more