Abiomed
Associate Quality Engineer (SPRs and Sustaining) / Electrical
Job#: 328568
Positions: 1
Posted: 09/08/2015
Job Type: Full Time
Location: Danvers, MA
Department: Quality
Salary: Commensurate with Experience
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Job Description

This position is responsible for the coordination, receipt, and decontamination of complaint samples. Position will perform or coordinate complaint investigations, closure, and verification. Position will support CAPA projects and nonconformance investigations as needed.

 

Principle Duties and Responsibilities:

 

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

 

  • Functions as the primary internal contact for customers entering complaints. Coordinates the complaint processes, including from receipt, decontamination, investigation, and storing of samples.
  • Processes returned used products in accordance with decontamination procedures established by Abiomed, as well as universal safety precautions.
  • Coordinates replacement orders or issuance of credit through the Customer Service department and Sales.
  • Performs product complaint investigations. Reviews failure investigations for thoroughness with respect to root cause identification, and corrective action determination.
  • Evaluates product complaint trends and prepares report. Drafts monthly and special reports regarding trends and corrective actions.
  • Initiates contact with Customer, Sales Representatives and other facilities regarding complaint information for the return of product.
  • Supports MRB process as needed. Ensures that non-conforming materials and products are dispositioned properly. Takes charge in driving corrective actions.
  • Supports CAPA projects as needed. Identifies and develops corrective and preventive actions as a result of internal and external complaints, trend analysis, and nonconforming material review process.




Skills/Requirements
  • Bachelor degree in Engineering or Sciences is required
  • Minimum of 1-3 years experience in medical device industry in electro-mechanical systems and/or cardiovascular devices preferred.
  • Demonstrates basic knowledge of quality engineering policies, principles and best practices, and FDA/ISO requirements.
  • Takes initiative, and demonstrates leadership and team work

ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.

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