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Supplier Quality Engineer

Location
San Diego, CA

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SummaryResponsible for the management, implementation, and continuous improvement of the supplier quality management systems in compliance with CFR 820 and ISO13485 quality requirements and all other applicable standards. Tasks and responsibilities: Apply QSR 21CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Management activities.Support the qualification of new suppliers/services provides according to company policy.Execute duties per the Supplier Quality Audit program.Execute and support activities to ensure effective monitoring of supply chain performance including supplier corrective actions (SCAR)Support the creation and management of quality agreements with vendor.Manage supplier change control and work with the Operation/Quality engineering group to evaluate the change impact to product performance.Lead and drive proactive supplier quality tools (e.g. scorecards, supplier risk management) and participate in supplier business reviews.Leading and/or supporting supplier related Non-conformance and CAPA.Carries out duties in compliance with established business policies. Preferred background:Bachelor's Degree in a biological science or engineering discipline. 5-7 years of relevant medical device experienceWorking knowledge of the technical principles related to in-vitro diagnostic device functionLater flow device experience is plus.Ability to read, interpret and understand technical and non-technical documents including product drawings, specifications, contracts and purchase ordersExperienced in root cause analysis and corrective action processes.Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, EN ISO 13485, EN ISO 14971:2012, CMDR).Experience with 21 CFR 820.50.ASQ Certified Quality Engineer or equivalent experience desiredAbility to travel approximately 15 to 20% domestic and international. About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffingu00ae Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please **** or email **** for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.nn 

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