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Project Engineer - (Supplier/ Medical Device)

Company:
LanceSoft Inc.
Location:
Raynham, Massachusetts, United States
Posted:
April 10, 2019

Description:

Goal:

• Meet all EU MDR requirements pertaining to packaging & labeling at suppliers for EU MDR Supply Chain Workstream.

• Reference EU MDR Supply Chain Workstream for Key Deliverables.

• Project Engineer (Contractor) will be working under the direction of local Clients Supplier Quality Management with dotted line responsibility to EU MDR Supply Chain Core Team (SQ Lead).

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.