Sr. Quality Engineer

We anticipate the application window for this opening will close on - 14 Oct 2025

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 Medtronics 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. (IQOQPQ) 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 : $110400 to $145200 per year

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The following benefits and additional compensation are available to those regular employees who work 20 hours per week : Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance / reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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

Required Experience :

Senior IC

Key Skills

APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 110400 - 145200