Medtronic Plc
Sr. Supplier Quality Engineer
Sr. Supplier Quality Engineer for Medtronic, Inc. located in Minneapolis, MN. Responsible for communicating technical objectives between Medtronic and suppliers. Coordinate with cross-functional groups in supplier selection process. Developing and maintaining incoming inspection procedures, ensuring inspector trainings and qualifying parts for SOQ program. Responsible for Supplier Change process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Responsible for Supplier and Medtronic CAPA (Corrective and Preventive Action) Supplier related Product and Process NCMR (Nonconforming Material Report) by working with the supplier to conduct root cause investigation, implement appropriate controls and perform effectiveness checks. Responsible for Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, Quality Performance Reviews. Execute supplier and component qualification and validation including drafting, Control Plans, PPAP (Production Part Approval Process), Medtronic qualify plans/RIR (Receiving Inspection Requirements), and Gage R& R (Repeatability & Reproducibility), DOE (Design of Experiments), and GD&T (Geometric Dimensioning and Tolerancing). Coordinate equipment Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation, pFMEA (Process Failure Mode and Effects Analysis) and Risk Assessments of suppliers, Test Method Validations and Measurement System Analysis. Utilize failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls. Utilize GMP (Good Manufacturing Practices) for Class II and Class III medical devices to ensure quality products and outcomes. Navigate the complexities of various government and industry regulations to include FDA QSR 21 CFR 820, EU Medical Device Directive (EU MDD 93/42 EEC), ISO 13485, ISO 9001, and ISO 14971. Multiple positions available. Position is open to telecommuting from anywhere in the United States. Requires up to 25% travel to suppliers within the U.S. and internationally. Basic Qualifications: Requires a Master's degree in Mechanical, Biomedical, Industrial, Electrical, or Manufacturing Engineering, Engineering Technology, Technology Project Management or related engineering field, and two (2) years' experience as a supplier, quality, or manufacturing engineer or related occupations; or Bachelor's degree in Mechanical, Biomedical, Industrial, Electrical or Manufacturing Engineering, Engineering Technology, Technology Project Management, or related engineering field, and five (5) years' experience as a supplier, quality, or manufacturing engineer or related occupations. Must possess at least two (2) years' experience with each of the following: Supplier Change Process evaluation and implementation; CAPA, Supplier related Product and Process NCMR; Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews; Supplier and component qualifications and validations, including Control Plans, PPAP, RIR, Gage R&R, DOE, and GD&T IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method; Validations, and Measurement System Analysis; Failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls; GMP for Class II and Class III medical devices; FDA QSR 21 CFR 820, EU MDD 93/42 EEC, ISO 13485, ISO 9001 and ISO 14971. Salary: $121,400 to $145,200 per year The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Sr. Supplier Quality Engineer for Medtronic, Inc. located in Minneapolis, MN. Responsible for communicating technical objectives between Medtronic and suppliers. Coordinate with cross-functional groups in supplier selection process. Developing and maintaining incoming inspection procedures, ensuring inspector trainings and qualifying parts for SOQ program. Responsible for Supplier Change process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Responsible for Supplier and Medtronic CAPA (Corrective and Preventive Action) Supplier related Product and Process NCMR (Nonconforming Material Report) by working with the supplier to conduct root cause investigation, implement appropriate controls and perform effectiveness checks. Responsible for Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, Quality Performance Reviews. Execute supplier and component qualification and validation including drafting, Control Plans, PPAP (Production Part Approval Process), Medtronic qualify plans/RIR (Receiving Inspection Requirements), and Gage R& R (Repeatability & Reproducibility), DOE (Design of Experiments), and GD&T (Geometric Dimensioning and Tolerancing). Coordinate equipment Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation, pFMEA (Process Failure Mode and Effects Analysis) and Risk Assessments of suppliers, Test Method Validations and Measurement System Analysis. Utilize failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls. Utilize GMP (Good Manufacturing Practices) for Class II and Class III medical devices to ensure quality products and outcomes. Navigate the complexities of various government and industry regulations to include FDA QSR 21 CFR 820, EU Medical Device Directive (EU MDD 93/42 EEC), ISO 13485, ISO 9001, and ISO 14971. Multiple positions available. Position is open to telecommuting from anywhere in the United States. Requires up to 25% travel to suppliers within the U.S. and internationally. Basic Qualifications: Requires a Master's degree in Mechanical, Biomedical, Industrial, Electrical, or Manufacturing Engineering, Engineering Technology, Technology Project Management or related engineering field, and two (2) years' experience as a supplier, quality, or manufacturing engineer or related occupations; or Bachelor's degree in Mechanical, Biomedical, Industrial, Electrical or Manufacturing Engineering, Engineering Technology, Technology Project Management, or related engineering field, and five (5) years' experience as a supplier, quality, or manufacturing engineer or related occupations. Must possess at least two (2) years' experience with each of the following: Supplier Change Process evaluation and implementation; CAPA, Supplier related Product and Process NCMR; Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews; Supplier and component qualifications and validations, including Control Plans, PPAP, RIR, Gage R&R, DOE, and GD&T IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method; Validations, and Measurement System Analysis; Failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls; GMP for Class II and Class III medical devices; FDA QSR 21 CFR 820, EU MDD 93/42 EEC, ISO 13485, ISO 9001 and ISO 14971. Salary: $121,400 to $145,200 per year The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.