QLTY & RELIABILITY ENGINEER

Internet/Company Website Posting

Quality & Reliability Engineer

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TE Connectivity in Plymouth, MN is looking for a Quality & Reliability Engineer, responsible for direct interaction and support and customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the Quality System. Complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Implement quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs). Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group. Develop and maintain the pFMEA process for manufacturing. Support/participate in regulatory agency and customer quality audits. Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability. Participate in initiating nonconformance report, Containment, root cause investigation, dispositions, and implementation of CAPA. Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues. Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements. Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies. Provide quality engineering support to sending sites during project transfers. Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.    

Requirements: Master’s degree in Mechanical Engineering, or related field (or foreign equivalent), plus 1 year of experience in the job offered, or in a related occupation.    

Special Requirements:  Requires 1 year of experience with the following:
1)    Quality compliance guidance per FDA QSR (21 CFR 820) and ISO 13485.
2)    Quality engineering knowledge in medical device manufacturing industry including Validation Master Plans, pFMEA process, Equipment Qualifications, Risk Assessment and Process Validations.
3)    Quality engineer supporting design control activities from transferring product development to commercial launch.
4)    FDA regulations, Catheter/minimally invasive experience in medical device industry.
5)    Statistical Analysis Skills including develop and execute test method validations, updating/establishing SPC and Gage R&R studies.
6)    Regulatory agency and customer quality audit participation/support experience in a medical device industry (FDA regulations).
7)    Problem Solving techniques, Six Sigma (Green Belt), CAPA Management, root cause analysis, corrective and preventive solutions, and continuous improvement of the Quality System.
May require employment and background checks.
Please apply at www.jobpostingtoday.com, enter job code 38068 and submit resume.