Supplier Quality Engineer

Client of TTI (TAJ Technologies, Inc.)

JOB TITLE: Senior Supplier Quality Engineer

LOCATION: Billerica, MA

DURATION OF PROJECT: 6 months or longer with possible extensions

PLEASE NOTE:

C2C and EAD-OPT candidates kindly do not apply.

Only W2 candidates can apply.

H1B transfer candidates are most welcome.

JOB SUMMARY:

Must hold a bachelor’s degree and require a minimum of 4+ years of experience.

Medical Device Experience and Electrical / Mechanical background.

Component / Product Qualification including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.

Support and lead Supplier Quality activities per Medtronic requirements.

Support and lead Product Qualification activities ensuring suppliers can deliver quality products, materials, and services.

Assess and qualifies suppliers according to Medtronic requirements.

Monitors products through the manufacturing cycle and resolves supplier-related problems before they occur.

Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.

Lead and develop the Product Acceptance Strategy for incoming inspection and associated test method validation for all internal Medtronic Test Methods.

Lead and support Supplier Change Requests.

Lead Supplier Related NCMRs through disposition, corrective and preventative actions with Supplier.

Assist in Approved Supplier List (ASL) Activities.

Provide routine communication and updates to leadership regarding supplier activities and performance.

Responsibilities:

Ensure that suppliers deliver quality parts, materials, and services.

Qualify suppliers according to company standards and may administer a Certified Supplier Program by receiving inspection to ensure cost effectiveness.

Monitors parts from acquisition through the manufacturing cycle and communicate and resolve 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 supplier’s internal functions to assess their overall performance and provides feedback on 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 with 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