Sr. Quality Engineer
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Job Location:
Brooklyn Park, MN - USA
Yearly Salary:
$ 109000 - 145200
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Description:
Sr. Quality Engineer for Medtronic Inc located in Brooklyn Park MN. Responsible for developing and maintaining quality standards for processing materials collaborating with engineering and manufacturing teams and implementing process improvements. The position also includes conducting quality assurance tests performing statistical analysis and ensuring corrective measures meet reliability standards. Responsible for technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products that potential risks are analyzed and controlled and that product/system performance is quantifiably predicted. Perform Risk Mgmt. Deliverables to include Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis. Support Design and Process Control deliverables to include Product Performance Specifications Design Verification Design Validation approve product drawings/prints Process Characterization and Process Validation. Provide support for Variable and Attribute Test Method Development and Validation. Provide support for Complaint and Product Failure Investigations post market root cause analysis Corrective and Preventive Actions (CAPA) and Non- Conforming Material Requests (NCMR). Navigate government and quality regulations to include FDA 21 CFR part 820 and part 211 requirements and ISO 13485 ISO 9001 and ISO 14971. Utilize statistical tools and software to include Design of Experiments (DOE) ANOVA Confidence and Tolerance Limits Gage R&R Capability analysis and Six Sigma Methodology in auditing and ensuring quality outcomes. Provide specialized knowledge in the manufacturing process of Coating of medical devices for perfusion systems including Biocompatible coatings with and without Active Pharmaceutical ingredients (API) manufacturing of combination products. Coordinate Control Environment Area (CEA) Validations Control Environment Area Excursion Analysis and investigation and utilize computer and software packages to include MS Office Suite MS Project MS Access Minitab and SAP. #LI-DNI.
Basic Qualifications: Bachelors Degree or foreign equivalent in Nanotechnology Mechanical Industrial Chemical or Biomedical Engineering or related engineering field. Requires four (4) years experience in Quality Engineer for Medical devices. Must possess at least four (4) years experience in each of the following: Risk Mgmt. Deliverables to include Process FMEA and Product Hazard Analysis; Variable and Attribute Test Method Development and Validation; Design and Process Control Deliverables to include Product Performance Specifications Design Verification Design Validation Process Characterization and Process Validation; Complaint and Product Failure Investigations post market root cause analysis CAPA and Non-Conforming Material Reports; FDA 21 CFR part 820 and part 211ISO 13485 ISO 9001 and ISO 14971; DOE ANOVA Confidence and Tolerance Limits Gage R&R Capability analysis and Six Sigma Methodology; Coating of medical devices for perfusion systems Biocompatible coatings with and without Active Pharmaceutical ingredients (API) manufacturing of combination products; Control Environment Area (CEA) Validations Control Environment Area Excursion Analysis and investigation.
The position reports to Medtronic Inc. 7611 Northland Drive Brooklyn Park MN 55428.
Salary: $109000 to $145200 per year.
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1000. Refer to the program guidelines located at
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:
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
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
