Sr. Quality Engineer (Finance)
We anticipate the application window for this opening will close on - 11 Jul 2025
Position Description:
Sr. Quality Engineer for Medtronic, Inc. located in Menlo Park, CA. Responsible for products in the form of finished medical devices within the Ear, Nose, Throat (ENT) operating unit (OU) by supporting manufacturing operations, evaluating compliance of materials and processes with specifications, and customer requirements in compliance. Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished materials product. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Support Internal and External audit preparation and activity which includes application and maintenance of quality standards for all activities associated. Navigate government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union(EU) Medical Device Regulation (MDR), State of the Art (SOTA) and Good Manufacturing Practices (GMP). Coordinate Risk Assessments, Preliminary Hazard Analysis (PHA) and Process Failure Mode Effect Analysis (PFMEA). Participate in preparing, critically reviewing, and approving Non Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs)
Investigations, Complaints and validation activities using QAD, SAP, Agile and Trackwise while providing expert Quality Assurance (QA) technical direction and solutions as appropriate. Leverage Process Improvement Tools to support operations including DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping. Leverage Design of Experiments (DOE) methods to establish process development as well as Statistical analysis tools for process capability including Cpk/Ppk, Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Develop V&V (verification and validation) using Installation Qualification, Operational Qualification, and Process Qualification (IQ/OQ/PQ). #LI-DNI.
Basic Qualifications:
Master's Degree in Biomedical Engineering, Biomedical Sciences, Mechanical Engineering, or Industrial Engineering or related discipline and two (2) years of experience as a Quality Engineer or related occupation in medical device industry Must possess at least two (2) years' experience with each of the following: 21 CFR Part 820 QSR, ISO 13485, EU MDR, SOTA, and GMP; Risk Assessments, PHA, and PFMEA; NCMR & CAPA; DMAIC, Root Cause Analysis, 5Whys, Fishbone, and cause mapping; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; V&V and IQ/OQ/PQ.
Salary: $125,000 to $158,400 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:
Medtronic benefits and compensation plans
