POSITION DESCRIPTION:

Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Fridley, MN. Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations. Coordinate complaint investigations for Medtronic’s returned implantable devices. Accept and handle returned implantable devices, cleaning and sterilization process. Coordinate test results, clinical data, DHR (Device History Records) and product performance data. Perform Complaint analysis, complaint trending, predictive for newly developed products.. Responsible for Risk Mgmt. and Quality Controlled documents by updating relevant procedures and risk documents including (PHA, DFMEA and PFMEA) in compliance with the requirements of ISO 14971, ISO 13485, ISO 9001 and FDA QSR Part 820 and implementing best practices including (GDP) Good Documentation Practices. Perform Root Cause Analysis on identified non conformances by implementing methodological problem solving including DMAIC Process, Ishikawa Diagrams, Pareto Analysis, 5 Why Analysis. Implement process improvements by implementing Lean Six Sigma Techniques to include (COS) Cell Operating System, 5S, Gemba, Poka Yoke and Heijunka. Perform (TMV) Test Method Validations, Process Validations including Installation Qualification, Operational Qualification, Performance Qualification. (IQ,OQ,PQ) using effective Analysis including (MSA) Measurement System Analysis, Gage R&R Study, DOE (Design of Experiments) and application of statistical tools including Capability Analysis (CPK and PPK), SPC (Statistical Process Control), Control Charts, and ANOVA. Responsible for investigating identified non-conformances through formal investigation process including (CAPA) Corrective and Preventive Action. Responsible for combination(pharmaceutical and medical devices) products (FDA 21 CFR Part 4). Leverage knowledge from being a (ASQ) American Society of Quality Certified Quality Engineer (CQE).

BASIC QUALIFICATIONS:

Masters’ Degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing or quality engineer or related occupation in manufacturing or quality engineering.
Must possess at least two (2) years’ experience with each of the following: Handling of returned implantable devices, cleaning and sterilization process; Review and analysis of test results, clinical data, DHR & product performance data; ISO 14971, ISO 13485, ISO 9001, FDA QSR Part 820 & GDP; RCA, DMAIC Process, Ishikawa Diagrams, Pareto Analysis and 5 Why Analysis; Lean Six Sigma Techniques, (COS) Cell Operating System, 5S, Gemba, Poka Yoke and Heijunka; SPC, Control Charts, IQ, OQ, and PQ; MSA, Gage R&R Study, DOE, Capability analysis (CPK, PPK), SPC, Control Charts, & ANOVA; CAPA; and Combination [pharmaceutical and medical device] Products, (FDA 21 CFR Part 4). The following Certification is required: ASQ CQE. Position works a hybrid model and will be onsite in Fridley, MN 3/4 days per week.
Salary: $110,400 to $145,200 per year

Please refer the Job description for details