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Planet Pharma

Sr. Supplier Quality Engineer - Medical Devices

Planet Pharma, Minneapolis, Minnesota, United States, 55400

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Sr. Supplier Quality Engineer - Medical Devices Our client, a leading Medical Device company, is seeking an experienced Sr. Supplier Quality Engineer for its growing team within new product introduction. We are targeting someone who has a strong supplier quality background, supplier controls, component qualification, PPAP, manufacturing process knowledge and validation; project management experience. This person will be the first point-of-contact for suppliers.

Responsibilities

Establish supplier controls strategy for new or legacy suppliers from a component supplier or a contract manufacturer

Qualify components and execute activities from Policy-019 (Purchasing and Suppliers Controls) to support the new product development launch

Root cause analysis investigation for supplier issues or non-conformance situations identified internally

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

Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur

Develop and prioritize 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

Evaluate suppliers\' internal functions to assess their overall performance and provide feedback in assessment of their operation

Requirements

Medical Device background

Strong supplier quality background, supplier controls, component qualification, PPAP, manufacturing process knowledge and validation; project management experience

Bachelor\'s Degree within an engineering realm

5+ years of experience

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Medical Equipment Manufacturing and Biotechnology Research

Minneapolis, MN — salary range not specified in this refined description.

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