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Project Engineer
Ref No.: 18-08220
Location: Raynham, Massachusetts
Start Date / End Date: 07/06/2018 to 07/06/2020

Scope of Work to include the following:
1) Support definition and clarification of EU MDR supplier related process requirements;
2) Support update of applicable Supplier Quality Procedures and Work Instructions;
3) Support Review & Approval EU MDR Change Projects as applicable;
4) Support Supplier Quality Functional Impact Assessments as applicable;
5) Support Review & Approval of EU MDR Change Orders as applicable;
6) Support Review & Approval of PVE Protocols and Reports as applicable;
7) Execute PVE's for supplier related Component Packaging Qualification as applicable;
8) Execute PVE's for supplier related Component Label Stock Qualification as applicable;
9) Update supplier related Inspection Criteria for Component Packaging & Labeling as applicable;
10) Complete supplier related Adaptiv CO Change Tasks upon approval of PVE's as applicable;
11) Partner with Packaging Engineering, Labeling, and Supply Chain to support EU MDR supplier communication and rollout of EU MDR Supply Chain Workstream activities;
12) Partner with EU MDR Supply Chain Workstream Core Team to support tracking and expediting of supplier related product codes to meet project FPO deadlines;

Other related tasks may be assigned at the discretion of local Supplier Quality Management and/or the EU MDR Supply Chain Workstream Core Team (SQ Lead).

EDUCATION & EXPERIENCE REQUIREMENTS:
· A minimum of a Bachelor's degree or equivalent in Engineering and/or Technical Field is required.
· Five Years experience as Project Engineer, Quality Engineer, or equivalent role within regulated industry is required.
· A minimum of 2+ years of experience in a medical device and/or pharmaceutical industry is required.
· Familiarity with ISO-13485 and FDA QSR is required.
· Background in Supplier Management and Process Validation / Verification is required.
· Experience with GD&T, Inspection Methods, and Drawing Review/Approval is required.
· Excellent organizational skills and attention to detail is required.
· Must be able to work independently and prioritize with limited supervision.
· Strong written and oral communication and interpersonal (listening) skills. Excellent computer, communication, and written skills are required.
· Proficient in Microsoft Office suite is required.