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Mechanical Designer Quality Engineer Location: US-MA-Mansfield Email this job to a friend
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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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