Medical Device Supplier Quality Engineer

Technical Skills Must Have:
Gage R & R Analysis

Nice To Have:
•    APQPPPAP certification
•    APQP PPAP Preparation

Job Description -
Responsibilities may include the following and other duties may be assigned.
•    Ensure that suppliers deliver quality parts, materials, and services.
•    Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
•    Monitors parts from acquisition through the manufacturing cycle and communicate and resolves supplier-related problems as they occur.
•    Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
•    Evaluates suppliers'''''''''''''''' internal functions to assess their overall performance and provides feedback in assessment of their operation.
•    Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
•    Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
•    Collaborate 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.

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The SQE supports supplier change requests (SCRs) to enable product ramp‑up for Lung Health at the Cheshire facility. The role works closely with suppliers and cross‑functional teams to evaluate, coordinate, and implement supplier changes while maintaining quality and regulatory compliance. This individual is a self‑starter who can track multiple timelines, drive alignment across functions, and help ensure changes are executed efficiently to support production needs.

 What are the top 3 things you are looking for in a candidate’s experience:
•    Experience supporting supplier change requests or supplier quality activities in a regulated manufacturing environment (medical device, pharma, or similar), including documentation and change control.
•    Ability to work cross‑functionally with suppliers, engineering, operations, and quality teams to coordinate change implementation and resolve issues.
Strong project and timeline management skills with the ability to track multiple supplier changes and drive tasks to completion during production ramp‑up.
•    This is the hourly rate your cost center pays for work completed. This is the candidates pay + supplier overhead and profit.
•    (Agencies will be submitting candidates at a competitive market rate but we do understand that sometimes you have a budget that you cannot go above. Please provide me with a max bill rate for my knowledge so I can keep in mind.)
•    Education Required: Bachelors Years’ Experience Required: 1-5 years