Supplier Quality Engineer II
Supplier Quality Engineer II
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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.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first upholding product quality and maintaining the highest ethical standards in our business relationships and programs.
In this exciting role as a Supplier Quality Engineer II you will have responsibility for management of suppliers within the Plymouth MN SQE team. You will be accountable for changes to existing supplied products and processes as well as oversight of performance and improvement activities.
You will also lead the oversight of supplied products ensuring conformance to purchased materials or finished devices 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.
Perform timely investigations into supplier quality issues. Lead activities related to Material Review Board (MRB) Nonconformances (NCMR) Supplier CAPAs and Inspections.
Responsible for Supplier/Part Setup and Management in multiple applications.
Coordinate the addition/change of New Suppliers to the Approved Supplier List (ASL).
Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy Approved Supplier List coordination Supplier Owned Quality deployment and Control Plans for new products.
Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
Support supplier change notices and assess their impact to MTC manufacturing operations to existing material inventory to acceptance procedures and part number configurations.
Stay abreast of applicable regulatory requirements. Actively seek out opportunities to understand current industry direction.
Applies understanding of statistical concepts to monitor suppliers and correct supplier quality issues.
Drive continuous improvement using such tools as Lean Six Sigma and Kaizen. All activities must be performed in compliance with the Quality System.
Onsite
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. Were working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Must Have: Minimum Requirements
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 0 years of work experience in Engineering and/or Quality
Nice to Have
Supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
ASQ Lead auditor certification.
Working knowledge of Quality System Regulation (QSR 21 CFR 820) and ISO 13485.
Strong written and verbal communication skills in the English language.
Working knowledge of statistical methods associated with six sigma and quality control.
Ability to maintain a professional and respectful relationship with coworkers and company.
Demonstrated working knowledge of supplier controls process validation supplier and internal auditing failure investigation techniques statistical quality control protocol/report preparation and non-conforming product controls
PC skills MS Office (Word Excel PowerPoint and Project).
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 law. In 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
