JVT Advisors

Quality Engineer

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Location: Indianaplois, Indiana 46218
Employment Type: Contract

Job Description

 

6 Months

Job Description: Provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations.

Responsibilities:

  • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
  • Leads and implements various product and process improvement methodologies
  • Develops various inspection techniques and procedures to ensure product integrity to design specifications
  • Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems

Requirements:

  • Bachelor’s Degree in Engineering or related field required or 2-5 years’ experience in quality engineering role within a regulated industry
  • 5-7 years’ experience in medical device or regulated manufacturing
  • Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.)

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Justin McKay

Principal Life Sciences Recruiter

With extensive industry experience and specializing in our Life Sciences & Technologies practice area, Justin enjoys helping candidates find their next perfect employment opportunity.

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