Sr. Quality Engineer
Medtronic
Position Description:
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. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. 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 Mgmt. 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. #LI-DNI.
Basic Qualifications:
Master’s degree or foreign equivalent in Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field and two (2) years of experience as a quality engineer or related occupation. Must possess at least two (2) years of experience with each of the following: ISO 9001; TMV, GRR, and IQ/OQ/PQ; CAPA using Track Wise, and QMS software tools; Non-Conformance, Change Control, Deviations, and GMP; SAP; FMEA, validation, methodical problem solving, product design, and manufacturing engineering; SPC and AS; and Minitab.
The position is located at Medtronic, Inc., 880 Technology Park Dr., Billerica, MA 01821.
Salary: $125,600 to $145,200 per year
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.
Further details are available at the link below: