QUALITY ASSURANCE SPECIALIST

Cremona Drive near Hollister Avenue, Goleta CA

Description

QUALITY ASSURANCE SPECIALIST (QAS) MAIN RESPONSIBILITIES • The Quality Assurance Specialist (QAS) will have considerable Quality Management System (QMS) knowledge in a medical device company. • The QAS will support senior QA and RA staff assuring the organization, products and processes conforms to all QMS requirements including; applicable standards, statutory, regulatory, customer, product and internal requirements and ensures confidence in the quality of our products. • The QAS responsibilities will encompass both new product development and the manufacture of released products. ESSENTIAL DUTIES AND RESPONSIBILITIES Executes Quality Assurance processes in the release of medical devices for microsurgery by performing the following duties. Other duties may be assigned. • Support the implementation, maintenance, audit and execution of the QMS including the Quality Manual, Quality Procedures, Work Instructions and Forms • Administration and technical support of internal and external audits to maintain certification to standards. Familiar with appropriate standards including but not limited to ISO 13485, FDA 21 CFR 820, MDR and IEC 60601 • Administration of external QA, RA and Certification Lab registrations and/or certifications. Maintain accurate databases of company contact info, product registrations and fees. Administration and support of related on-site audits. • Management of document control and retention of all controlled quality records • Management of the Engineering Control Order (ECO) and Document Control Order (DCO) processes • Support the escalation of quality issues and follow up of action plans • Support the administration of the Approved Vendor List for suppliers and contract manufacturers • Support the administration of ongoing calibration of tools and test equipment • Documenting and maintenance of departmental Work Instructions • Technical Writing to document the above essential duties and responsibilities • Work professionally and collaboratively in a team environment with external and internal stakeholders • Other support to QA and RA staff as assigned by the VP of Program Management, QA and RA If you are interested and feel you may qualify for this job, please contact us today! VOLT is an equal opportunity employer.