Medtronic
Overview
Sr. Quality Engineer for Medtronic, Inc., located in Billerica, MA. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Navigate various government and industry regulations including ISO 9001. Develop and execute protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Special Product and Process Validations, Test Method Validations (TMV), and Gage R&R (GRR). Coordinate Corrective & Preventive Actions (CAPA) using Track Wise or similar Quality Management Systems (QMS) software tools, Nonconformance, Change Control, Deviations, and Good Manufacturing Practices (GMP). Utilize various Enterprise Resource Planning (ERP) systems to include SAP manufacturing systems. Coordinate Failure Mode and Effects Analysis (FMEA), validation, methodical problem solving, product design & manufacturing engineering. Utilize Statistical Process Control (SPC) and Acceptance Sampling (AS). Utilize Minitab for data analysis and visualization. Must be able to work 2nd shift (2 pm to 10:30 pm). Relocation assistance not available for this position. Responsibilities
Develop, implement and maintain quality standards and protocols for processing materials into finished or partially finished products. Collaborate with engineering and manufacturing to ensure quality standards are in place. Design and execute inspection, testing and evaluation methods for product and equipment quality. Ensure compliance with government and industry regulations (ISO 9001). Develop and execute IQ/OQ/PQ protocols, special product and process validations, TMV, and GRR. Coordinate CAPA using TrackWise or similar QMS tools; manage Nonconformance, Change Control, Deviations and GMP requirements. Utilize ERP systems (including SAP) for manufacturing processes. Coordinate FMEA, validation activities, problem solving, and cross-functional product design and manufacturing engineering efforts. Apply SPC and acceptance sampling; use Minitab for data analysis and visualization. Perform duties on 2nd shift (2:00 PM – 10:30 PM). Basic Qualifications
Master’s degree or foreign equivalent in Mechanical, Industrial, Chemical or Biomedical Engineering or related field. Two (2) years of experience as a quality engineer or related occupation. Experience with ISO 9001; TMV, GRR, and IQ/OQ/PQ; CAPA using TrackWise; QMS software tools; Non-Conformance, Change Control, Deviations, and GMP. Experience with SAP; FMEA, validation, problem solving, product design, and manufacturing engineering. Experience with SPC and AS; and Minitab for data analysis. Location: Medtronic, Inc., 880 Technology Park Dr., Billerica, MA 01821. Compensation and Benefits
Salary: $125,600 to $145,200 per year. The following benefits and additional compensation are available to 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). Benefits available to all regular employees: Incentive plans; 401(k) plan with 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 earnings minimums); and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earnings minimums). Regular employees are those who are not temporary (e.g., interns). Temporary employees are eligible for paid sick time as required by state law and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans Application window close indicator: 20 Nov 2025.
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Sr. Quality Engineer for Medtronic, Inc., located in Billerica, MA. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Navigate various government and industry regulations including ISO 9001. Develop and execute protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Special Product and Process Validations, Test Method Validations (TMV), and Gage R&R (GRR). Coordinate Corrective & Preventive Actions (CAPA) using Track Wise or similar Quality Management Systems (QMS) software tools, Nonconformance, Change Control, Deviations, and Good Manufacturing Practices (GMP). Utilize various Enterprise Resource Planning (ERP) systems to include SAP manufacturing systems. Coordinate Failure Mode and Effects Analysis (FMEA), validation, methodical problem solving, product design & manufacturing engineering. Utilize Statistical Process Control (SPC) and Acceptance Sampling (AS). Utilize Minitab for data analysis and visualization. Must be able to work 2nd shift (2 pm to 10:30 pm). Relocation assistance not available for this position. Responsibilities
Develop, implement and maintain quality standards and protocols for processing materials into finished or partially finished products. Collaborate with engineering and manufacturing to ensure quality standards are in place. Design and execute inspection, testing and evaluation methods for product and equipment quality. Ensure compliance with government and industry regulations (ISO 9001). Develop and execute IQ/OQ/PQ protocols, special product and process validations, TMV, and GRR. Coordinate CAPA using TrackWise or similar QMS tools; manage Nonconformance, Change Control, Deviations and GMP requirements. Utilize ERP systems (including SAP) for manufacturing processes. Coordinate FMEA, validation activities, problem solving, and cross-functional product design and manufacturing engineering efforts. Apply SPC and acceptance sampling; use Minitab for data analysis and visualization. Perform duties on 2nd shift (2:00 PM – 10:30 PM). Basic Qualifications
Master’s degree or foreign equivalent in Mechanical, Industrial, Chemical or Biomedical Engineering or related field. Two (2) years of experience as a quality engineer or related occupation. Experience with ISO 9001; TMV, GRR, and IQ/OQ/PQ; CAPA using TrackWise; QMS software tools; Non-Conformance, Change Control, Deviations, and GMP. Experience with SAP; FMEA, validation, problem solving, product design, and manufacturing engineering. Experience with SPC and AS; and Minitab for data analysis. Location: Medtronic, Inc., 880 Technology Park Dr., Billerica, MA 01821. Compensation and Benefits
Salary: $125,600 to $145,200 per year. The following benefits and additional compensation are available to 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). Benefits available to all regular employees: Incentive plans; 401(k) plan with 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 earnings minimums); and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earnings minimums). Regular employees are those who are not temporary (e.g., interns). Temporary employees are eligible for paid sick time as required by state law and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans Application window close indicator: 20 Nov 2025.
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