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Mechanical Designer Quality Engineer
Location:
US-MA-Mansfield
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Requirements:

  • Hand on experience in Medical Device DHF Remediation documentation.
  • Review the Problem Description and Problem type using a defined template and identify incomplete gaps
  • To develop and deliver codes for the work assigned in accordance with time, quality and cost standards.
  • Preferable to have knowledge of Quality Management Systems based on ISO 13485:2016.
  • Preferable to have knowledge of Risk Management Systems based on ISO 14971:2012.
  • Proactively work towards being a better problem solver while developing methods and parameters, project methodology and/ or project proposals.
  • Responsible for on-time projects delivery and to ensure the Quality of deliverables.
  • Cross functional team interaction and should have good experience of working in an onsite / offshore model.
  • Experience in EU Medical Device Regulation (2017/745) & FDA 21 CFR part 820.

Katalyst HealthCares & Life Sciences Inc

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