Quality Systems Specialist

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

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
• 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

• 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.