Quality Systems Specialist Elixir Medical - 2.9 Milpitas, CA Job Details $38.50 - $45.50 an hour 11 hours ago Qualifications Quality control corrective actions CAD software Content creation for technical audiences Quality records maintenance Supplier corrective action implementation 5 years Computer literacy Preventive action implementation Engineering Microbiology testing Document control experience within manufacturing industry Technical writing experience within manufacturing Filing Data reporting Corrective and preventive actions (CAPA) GMP Windows ISO certification audits Microbiology Quality reports Supplier audits Supplier audit compliance assessment Vendor compliance management Bachelor's degree in engineering Production validation processes Medical device manufacturing facility experience Pharmaceutical company experience Compliance documentation Supplier development Desktop applications Full Job Description 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. 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.