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Hayward, CA
... Follow FDA regulations, Good Manufacturing Practices (GMP), general safety and manufacturing procedures, company practices and policies. Cormatrix, (Manufacturing) Operation Associate April 2012 – December 2015 Responsible for the performance of ...
- 2023 Nov 21
Fremont, CA
... Select contract labs for formal stability program and product release, qualify them for compliance and GMP per FDA and Health Canada requirement. Conduct external GMP audit at contract lab, supplier, and contract manufacture in compliance with FDA, ...
- 2023 Nov 17
San Francisco, CA
... & EHS Oversee and lead the Facilities/maintenance functions to ensure proper operations and maintenance of all building systems in alignment with quality requirements of FDA for Medical Device Manufacturer Registration, ISO 13485, & MDSAP. ...
- 2023 Nov 12
Alameda, CA
... processes for building medical devices • Constant training to Ensure SOP (Standard operation practices) are up to date within FDA requirements • Ordering of materials needed for assemblies • Processing NCMR requests and scheduling with coordinating ...
- 2023 Nov 06
Pleasanton, CA
... Caire is the first company to receive FDA approval for it’s At Home asthma monitoring device. • Investor and Advisor Medea Healthcare, Medea Technology 2019 - 2021 Medea Medical and Medea Technology (Tech Centrix) are both divisions of Medea, Inc. a ...
- 2023 Oct 30
Redwood City, CA, 94063
... Have had successful CMC submissions and interactions with FDA and EMA. Efforts have resulted in approval of many drug products along with their commercial launches Experience with small as well as large sized molecules from various therapeutic areas ...
- 2023 Oct 27
Atherton, CA
... Assisted clinical trial physicians prepare clinical evaluation reports, product filings with European Medical Device regulations in addition to FDA officers. Assisted with regulatory affairs development, reports and compliance. Worked closely with ...
- 2023 Oct 21
Livermore, CA
... Built strategic plan to obtain CE Mark and FDA clearance. Start-Up Computer Company - Successful profit improvement achieved through improved production methods and fund raising of $50 million. Automotive Parts Manufacturer (Python Injection) – ...
- 2023 Oct 20
Martinez, CA
... Extensive knowledge with QA/QC requirements within FDA regulated medical and pharmaceutical environments (Class I/II), including CE Mark, CMDCAS, MDD and MDR. Leadership capability to accelerate performance of people individually or in a team ...
- 2023 Oct 13
San Francisco, CA
... Responsible for business requirements processes, development, and deployment, supporting IT solution for Class III Medical Device, and FDA regulation, cGMP, RIM. − Working knowledge of Software development and SQA enterprise B2B, B2C, SaaS, CRM, PLM ...
- 2023 Oct 02