- Abbott (Sylmar, CA)
- …Work with design engineering in the completion of product verification and validation . + Support all Divisional initiatives as identified by divisional management ... experience and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971. + Solid communication and interpersonal… more
- ManpowerGroup (San Diego, CA)
- …**Preferred:** + Experience with medical device regulations (ISO 13485, IEC 62304, FDA 21 CFR Part 820). + Familiarity with cloud testing and post-market ... software validation . + Strong interpersonal and leadership skills, with the ability to work across global teams. **We are looking for the candidate who are eligible… more
- Abbott (Alameda, CA)
- …and other release documentation for products used in design verification/ validation testing, clinical investigations, research use and demonstration purposes. + ... such as medical devices or pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. +… more
- ThermoFisher Scientific (Fremont, CA)
- …change control and Oracle ECO process. + Lead and complete process validation as needed. + Initiate, evaluate, and support investigations for non-conformances, ... compliance for medical devices or diagnostics. + Strong technical skills in FDA , GMP, ISO 13485 compliance, process improvement, and development. + Outstanding… more
- Teleflex (Pleasanton, CA)
- …all phases of product development including design, implementation, verification, validation , and manufacturing. * Exceptional verbal and written communication ... Stabilized Hyaluronic Acid (NASHA) a plus * Expertise with ISO 13485, MDD, and FDA QSR requirements. The pay range for this position at commencement of employment is… more
- Amgen (Thousand Oaks, CA)
- …and GMP activities + Clearly understands and applies knowledge of regulatory requirements ( FDA , ICH, USP, etc.) to completion of projects + Leads and/or participates ... synthetic organic chemistry, chemical process development, process characterization and validation , and technology transfer + Excellent technical communication skills,… more
- Amgen (South San Francisco, CA)
- …vivarium. + **Regulatory knowledge:** Experience handling GxP data and system validation . Knowledge of regulatory requirements affecting laboratory data (eg, FDA ... 21 CFR Part 11, GLP, GCP). + **Scientific Software Expertise** : Experience using or supporting platforms from scientific software providers such as Genedata, StudyLog, Revvity, Proscia, Thermo, Benchling, IDBS, Biovia, etc. + **AI Use Cases:** Experience in… more
- Abbott (Sylmar, CA)
- …lead clinical design documentation such as user needs, feature definition, and design validation , and drives them to on-time and high quality completion. + Drives, ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Curia (Camarillo, CA)
- …transfers, and validations + Perform QC method development + Perform cleaning validation studies + Assist with the evaluation of new equipment and processes ... software, including Microsoft Office Suite and instrument manufacture-based systems + Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …CMC Analytical Development/Operations and IND/IMPD Submissions + Strong Understanding of FDA and ICH guidelines relating to registration, quality, and compliance ... substance and drug product. + Experience with analytical method development, validation , and control strategies of biologic products + Strong communication skills-… more