Johnson Service Group, is looking to hire a Quality Assurance Analyst for a privately held commercial medical device company in San Diego.

This role is Direct Hire | Onsite | The salary range for this position is between
$75K - $100K, based on experience.  

Essential Functions: Assist with quality system supplier audits as required. Author, review and approve SOPs, protocols, test reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and internal procedures. Maintain Quality Activities - deviations, non-conformances, CAPAs, customer complaints, process change controls, recalls, etc. Coordinate and lead investigations for corrective and preventive action (CAPA). Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality. Review, consult, and approve (as authorized) risk analysis performed for ECOs, NCMRs, recalls, etc. Manage process engineering change orders and maintain controlled documents. Investigate and works with other departments to resolve quality issues related to area assigned. Work with manufacturing on the development and incorporation of Risk Management and compliance to standards during all design phases for new and/or product enhancements. Participate in internal and external compliance audits. Provide day-to-day guidance and training to other QA personnel, as required. Support Quality system training and participates in the development of training programs regarding all aspects of producing quality products. Performs trending of established quality metrics. Plan and schedule projects in a manner consistent with corporate objectives. Work with product development staff to ensure that products under development are compliant with FDA and ISO requirements.  Education/Experience Requirements: Bachelor's degree in life science or related field or the equivalent combination of education and/or experience. Engineering degree preferred. 5+ years' quality experience, preferably in biotech or Medical Device/IVD industries (GMP regulated environment) working in a Quality Assurance role Required Skills: Knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).  
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.