Supplier Quality Engineer II - Minneapolis, MN
Supplier Quality Engineer II - Minneapolis, MN
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$ 77600 - 116400
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver resultsthe right way. Thats the Medtronic Mindset our cultural norms. Our brand is rooted in action not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better healthier lives.As a member of Supplier Quality Engineering at Medtronic Energy and Component Center (MECC) you will be responsible for management of external suppliers to MECC. You will lead oversight of supplied products ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls FDA and international requirements and Quality System Regulations.
Responsibilities may include the following and other duties may be assigned.
Ensure that suppliers deliver quality parts materials and services.
Lead cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.
Lead and/or participate in corrective/preventiveaction teams in resolving supplier-related issues (e.g. nonconformances CAPA activities audit findings complaint investigations etc.).
Define component qualification strategy (PPAP) partner with suppliers to develop qualification plan report performance and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development as defined by procedures. Define control plans to ensure appropriate acceptance activities.
Evaluate and act as a lead in processing and approving supplier change requests.
Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
Evaluate suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation.
Provide technical guidance and quality compliance for Supplier Quality engagement throughout the products lifecycle. Including implementing strategies for driving product quality and continuous improvement ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards regulatory requirements and customer requirements.
Develop and deliver the Product Acceptance Sampling Strategy Approved Supplier List coordination Supplier Owned Quality deployment and Control Plans for existing products.
Formulate deliver and/or manage projects assigned and works with other stakeholders to achieve desired results.
Support internal and external audit and inspections including preparation and resolution of audit and inspection findings.
Collaborate cross-functionally with internal stakeholders and interact with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.
Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering Science or technical field with 2 years of work experience in Engineering and/or Quality
OR Advanced Degree in Engineering Science or technical field with no years of work experience in Engineering and/or Quality
Nice to Have
Experience in polymers chemical or materials engineering
Recent experience in a regulated industry such as automotive aerospace or medical device
Medical device experience strongly preferred
Design qualification and validation experience
Previous experience in the control of non-conforming product
Strong problem solving investigation and communication skills
Working knowledge of ISO 13485 ISOCFR820
Experience in applying DMAIC / Lean Six Sigma principles; Green Belt or Black Belt certification
Good statistical data analysis skills including SPC
Root cause analysis methodology
Risk Management or CAPA experience
Experience in Automated Optical Inspection Validation
Excellent verbal and written communication skills
Ability to interface with internal customers suppliers and external regulatory agencies
High attention to detail and accuracy
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
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
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Employment Type
Full-Time
