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Principal Supplier Quality Engineer


Littleton, MA 01460
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Job Details

Principal Supplier Quality Engineer


Littleton, Massachusetts, United States

Requisition #:


Post Date:

Dec 03, 2020

**Careers That ChangeLives**

In this exciting role as
a **Principal Supplier Quality Engineer** the primary focus of
responsibility will be supporting Released Product Management (RPM) with
supplier management activities.

The **RestorativeTherapies Group** develops life-restoring therapies and healthcare
solutions that span the care continuum; integrating technologies and applying
clinical and economic evidence to increase patient access, improve efficiency
of procedures and deliver successful patient outcomes.

**A Day in the Life:**

Responsibilities may
include the following and other duties may be assigned.

+ Ensures that suppliers deliver quality parts, materials,and services.

+ Qualifies suppliers according to company standards andmay administer a Certified Supplier Program in receiving inspection toensure cost effectiveness.

+ Monitors parts from acquisition through themanufacturing cycle and communicates and resolves supplier-relatedproblems as they occur.

+ Develops and prioritizes an auditing schedule to ensurethat designated suppliers are audited on a regular basis to ensure goodmanufacturing practices (GMP) and quality standards are met.

+ Evaluates suppliers' internal functions to assess theiroverall performance and provides feedback in assessment of theiroperation.

+ Some individuals may have responsibilities that includePre-Market Supplier Quality and duties may include: Provides Pre-MarketQuality Engineering support to New Product Development (NPD) working inpartnership with the Component Engineering and Post-Market SupplierQuality Teams, to deliver quality parts, materials, and services, preventdefects, and allow Medtronic to provide customers with the highest qualityand reliable products.

+ Provides technical guidance and quality compliance forSupplier Quality engagement throughout the NPD lifecycle on newlyqualified parts from NPD and implementing strategies for driving productquality and continuous improvement, ensuring purchased products andcomponents are manufactured and qualified in accordance to applicableindustry standards, regulatory requirements, and customer requirements.

+ Collaborates with Component Engineers to develop anddeliver the Product Acceptance Sampling Strategy, Approved Supplier Listcoordination, Supplier Owned Quality deployment, and Control Plans for newproducts.

+ Provide tactical process improvementand change management support to internal processes and external suppliersin resolving quality, productivity, and routine technical issues relatedto existing products.

+ Define Receiving Inspection requirements as requiredand associated test method validation for all internal Medtronic TestMethods.

+ Provide Quality individualcontribution and leadership for drawings,specifications, andlabelingimprovements for existing products.

+ Interface with external suppliers including managementof supplier corrective actions or to implement supplier changes as appropriate.

+ Interfaces with Production, Manufacturing Engineeringand Research and Development organizations to integrate new drawings,specifications or processes into the existing manufacturingsite/areas.

+ Disposition of Non-conforming material requiringadvanced process/technical knowledge.

+ Lead in resolving discrepancies between manufacturingand quality inspection criteria.

+ This person will also ensure thatproduct is manufactured in accordance with applicable industry standards,regulatory requirements, and customer requirements. In the case wherecorrective action is needed, this person will lead mitigation activities.Conducts training and supervises other engineers and inspection personnelin execution of Quality tasks and production.

+ Comply with applicable FDA and international regulatorylaws/standards and the Medtronic Code of Conduct.

**Must Have: Minimum Requirements**

+ Bachelors Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality

**Nice to Have:Preferred Requirements**

+ GMP, FDA QSR, MDD, EUMDR ISO 13485, and ISO14971 knowledge


+ Lead Auditor Certification or Training

+ Lean Six Sigma Black Belt Certification or Training

+ Organized and high level of attention to detail.

+ Excellent written and verbal communication skills.

+ Experience involving contract manufacturing process, product transfer, facility move, or acquisitions preferred.

+ Understanding of engineering principles focus on mechanical engineering and electrical engineering

+ Experience leading and participating in projects/project teams

+ Ability to create and work from engineering drawings and/ or specs, including tolerancing.

+ Development and qualification of tooling/equipment (IQ/OQ/PQ).

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)
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.
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