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Quality System Analyst
Ref No.: 18-00382
Location: Raynham, Massachusetts
Start Date / End Date: 04/01/2018 to 12/31/2018

We are currently seeking a Quality System Analyst who will analyze change orders and provide general guidance and support related to the change order process for the Codman, Client Orthopaedics, and Client Mitek operating companies, and creating and revising associated item master data for related products.

The Analyst performs their work in strict accordance with worldwide, local, and departmental procedures and with the highest degree of quality regulation awareness and compliance.

They maintain and comply with all department procedures and work instructions.

They may also support internal and external audits as requested.

They will have frequent contact with internal customers. These include Product Development, Marketing, Legal, Sales, Clinical, Operations, Finance, Quality and Regulatory departments, as well as document management teams at other Client Synthes facilities.

1. Ability to accomplish assignments with limited supervision.

2. Ability to prioritize work based upon communications with internal customers along with departmental goals and objectives.

3. Ability to perform high volume duties accurately and according to procedures.

4. Strong team-building skills, with the ability to function as a team player

5. Ability to clearly communicate with the team and internal customers

6. Ability to compile and populate change order data

7. Conscientious and attentive to detail, balanced with big-picture thinking.

8. Strong verbal/written communications skills.

9. A Bachelor's Degree preferred or a minimum of 2 years working experience in a highly regulated industry is required.

10. General office equipment and systems, Microsoft applications and software, is needed.

11. Must be able to offer practical solutions that minimize compliance risk while balancing business needs.

12. Our ideal candidate will have a minimum of 2 years working experience in the medical device industry, and experience with Product Lifecycle Management experience is highly preferred.

13. Experience working in compliance with Quality System Regulations, operating in strict accordance with written procedures, working with electronic change management systems, and experience working with ERP (enterprise resource planning) systems is highly preferred.

This position is based in Raynham, MA.