Clinton, MA
Date Posted: December 29, 2017
Employment Type: Contract To Hire
Job Id: 8119

Job Description

Position Summary

This individual will serve as a team member and/or leader for quality activities, including process improvements, MRB, validations, complaint investigations and internal audits. The primary work station is located in an office with some of the time spent in a cleanroom environment.

Key Responsibilities

  • Collaborates with supplier representatives and manufacturing engineering to maintain and improve existing products and to ensure regulatory and product performance requirements are met.
  • Participates in and leads investigation of corrective actions and implements robust solution s for process/device non-conformance; monitors complaint rates and initiates improvements where required; contributes to Material Review Board; support improvement initiatives
  • Develop and/or review Process Qualifications, Test Method Validations, Process Capability studies, Design of Experiment, production control plan. Review, Marketing and Product Spec Reviews, Regulatory compliance, Packaging and Sterilization
  • Provide direction in implementing First Article Inspection, In-Process Inspection, Sampling Plan, product / components testing, inspection and acceptance criteria
  • Writes, reviews, approves process validations/qualifications
  • Conducts product complaint analysis and failure investigations.
  • Analyzes process and product non-conformances and implements comprehensive corrective and preventive action plans.
  • Support continuous improvement initiatives
  • Lead/ participate in the Material Review Board.
  • Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.

Requirements:

  • Bachelor's degree preferred; or equivalent combination of 1 to 2 years of education 
  • A basic understanding of Quality Systems Regulations (QSR 21 CFR Part 820), MDD, ISO13485 is required.
  • ASQ certification strongly desired.

 

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