- Abbott (San Diego, CA)
- …Engineering teams to complete system /software requirements and other verification and validation tasks. + Ensure compliance to relevant FDA QSR, ISO ... the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds… more
- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more
- Abbott (Pomona, CA)
- …and assuring team compliance to all GMP's, safety, manufacturing and quality system procedures directly related to the manufacturing process and filling out the ... etc. + Ensuring that the manufacturing area is compliant with all required FDA , ISO and other applicable regulatory agency standards and documentation + Responsible… more
- Amgen (South San Francisco, CA)
- …or vivarium. + **Regulatory knowledge:** Experience handling GxP data and system validation . Knowledge of regulatory requirements affecting laboratory data ... degree** OR Master's degree and 2 years of Life Sciences, Bioinformatics, Computer Science, Information Systems , or related field experience **Or** Bachelor's… more
- Medtronic (San Diego, CA)
- …with customers (Spine Surgeons) to improve designs. + Understands verification and validation activities, ensuring products meet user needs, system requirements, ... and communicate results + Contributes and builds domain knowledge around spinal systems , their clinical use, and application via customer and field visits,… more
- BeOne Medicines (Emeryville, CA)
- …as analytical/QC SME in the areas of method qualification/ validation /transfer, specification development and management, stability studies, shelf-life updates ... and associated change control. Support global projects improve analytical/QC related systems and processes. **_Essential Functions of the_** **_job_** **_:_** +… more
- Medtronic (Irvine, CA)
- …high reliability and safety for NV products, and compliance to NV's Quality system procedures. + Implements and validate methods and procedures for inspections and ... Validation testing. + performs statistical analysis to support quality...(DFMECA). + Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971 and Good Documentation… more
- Medtronic (Irvine, CA)
- …qualifications. Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the ... best practices. Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to… more
- Bio-Techne (San Marcos, CA)
- …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
- Actalent (Irvine, CA)
- Job Title: Quality Management Systems (QMS) Specialist For immediate consideration, please apply directly to this job posting AND email me at biacosta ... Job Description We are seeking a detail-oriented and experienced Quality Management Systems (QMS) Specialist to ensure compliance with both internal and external… more
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