Clinton, MA
Date Posted: February 06, 2018
Employment Type: Contract To Hire
Job Id: 8188

Job Description

Quality Engineer II

Key Responsibilities

  • Collaborates with R&D, manufacturing engineering, customer, vendor and subcontractor representatives 

  • Work with cross-functional team to implement robust solutions for process/device 

  • Use data driven approaches to evaluate product performance and conformance

  • Analyzes process and product non-conformances and implements comprehensive corrective and preventive action plans.

  • Work with Product Development to ensure regulatory and internal requirements are met.

Requirements:

  • A minimum of five years of experience working in the medical device industry, with direct experience in design development activities.

  • A 4-year degree from an accredited college/university is required; a technical degree in an engineering or related discipline is required.

  • Deep understanding of Quality Systems Regulations (QSR 21 CFR Part 820), MDD, ISO13485 is required. 

  • ASQ and/or DFSS certification strongly desired.

 

 

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