Major Duties and Responsibilities
Responsibilities will include, but not be limited to:
- Maintain the quality system in compliance with ISO 13485, 21 CFR 820, and applicable GMP requirements, and help drive quality system improvements
- Maintain supplier quality system by working with cross-functional team to assess suppliers, review and update supplier files as needed, and tracking due dates in supplier system
- Maintain current versions of external standards in QMS
- Assist with complex document changes
- Assist teams with planning, preparation and review of quality documentation, including creation of procedures
- Perform assigned activities for administration of electronic QMS
- Provides data collection and general support for timely completion of complaint investigations
- Drive timely closure of CAPAs by assisting with investigations, facilitating corrective action implementation, and monitoring progress of CAPA phases
- Perform environmental monitoring and microbiological evaluation as needed
- Write and present reports to management and communicate changes to affected employees
- Participates in audits of documents and records, and provide support during external audits
- Execution of validation protocols and report generation
- Perform manufacturing and QC records review as needed
Qualifications
Experience
- 5-7 years of experience in small to mid-size Medical Device, Pharmaceutical, or other regulated companies (drug-device combination product a plus)
- Strong knowledge of quality systems (CAPA, audits, supplier control, document control, etc.)
- Prior experience with auditing to ISO 13485 and GMP
- Certification as an Internal Auditor to ISO 13485 is a plus
- Excellent technical writing and documentation skills
- Experience with process or software validations is a plus
- Ability to plan, organize, and manage multiple tasks simultaneously
- Demonstrated analytical and problem-solving capabilities
- Strong written, oral communication, and interpersonal skills
- Prior experience with process validation or software validation is a plus
- Computer skills:
- Basic experience with Microsoft Windows, Microsoft Office, Adobe Acrobat
- Prior experience with CAD software (Solidworks, etc) or PLM systems (Arena, Windchill, etc) are a plu
Education Requirements
- Bachelor’s degree in Engineering or Science discipline
- Additional background in microbiology is a plus
This position is based in Milpitas, CA and is an onsite position. The salary range of $110K – $125K based on factors including experience, skills, etc.
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- AA degree preferred
This position is based in Milpitas, CA and is an onsite position. The salary range is $38.50 – $45.50 per hour based on factors including experience, skills, etc.