Quality Engineer (Medical Device-Spine)

The Position Quality Engineer (Medical Device-Spine) Medical Equipment / Devices Information Technology - Quality AssuranceFull-time United States - California - San Diego - Vista The Compensation $ 80,000 -$91,000 Benefits - FullRelocation Assistance Available - NoCommission Compensation - No Bonus Eligible - Yes Overtime Eligible - No Interview Travel Reimbursed - NoDetailed DescriptionThe Quality Engineer's responsibilities include assisting with the development of quality systems, procedures and controls to ensure that products consistently meet performance and quality specifications. The Quality Engineer is a leader and strong technical resource who quickly, effectively and permanently resolves quality problems with internal and external customers and suppliers.Primary responsibilities are to:Take a leadership role on customer complaints to identify, coordinate and effectively resolve problems in a timely manner and maintain GMP and ISO 13485 complianceResponsible for complaint evaluations, analysis, trending and reporting of complaint data using standard statistical techniques and complaint processing and presentation softwareAssist with providing a strong quality direction in new product development and design change efforts to ensure that products meet performance/quality specifications and are highly manufacturableAssist with the development of critical-to-quality specifications, test plans, protocols, procedures, tools, meaningful metrics and controls for all aspects of manufacturing, packaging, cleaning, sterilization, inspection and shippingAssist with the development of plans and oversee the qualification of new suppliers and raw materials domestically and internationallyWork to quickly and permanently resolve supplier quality issuesEstablish procedures for statistical methods (DOE, sampling, and ANOVA)Specify and design inspection, test methods, fixtures, and set-ups for the Quality Control Department and vendorsDevelop and implement policies, procedures and work instructions for the Quality Control DepartmentManage equipment, preventative maintenance, and instrument calibration process and documentationMore About the Position 40+ Hours per Week Visa Candidates Considered - NoThe Candidate 2+ to 5 years of experience Management Experience Required - No Minimum Education - Bachelor's DegreeWillingness to Travel - OccasionallyThe Ideal CandidateThe ideal candidate has worked for these companies:Medtronic, DePuy, Synthes, Stryker, Nuvasive, Zimmer