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Date Added: Fri 28/05/2021

SR Or Staff Quality Engineer ( Medical Device Industry Experience Must )

San Jose, CA, US
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Company: SIGMAWAY

Job Type: Permanent, FullTime

Apply by EmailDirect Application at Location SJ - Onsite - may be open to fully remote. Duration 3-6 months CTH - open to visa candidates Title Sr. Quality engineer New Notes from client call Must haves medical device industry ndash will not consider anyone outside of medical class 2 or class 3. 13485 medical industry CQE ndash cert a plus if have robotics ndash a plus product has hardware and software accessories. mechanical components Need to understand how to test, regression bio compatibility validation documentation ndash write procedures, help engineering with studies. Need SR or Staff Quality Engineer 1-skills for design control assurance ndash 1SO 60601 -62604 ?? ndash need to understand this ndash understand software bugs. 4971 ndash risk management, 10993, ISO 62366 ndash usability 2- design review, voice of QA 10+ years of experience JR-Mid ndash Quality Engineer 3-5 years not involved in NPI more sustaining engineering and manufacturing supporting the quality contact GNT ndash how to support material certification Material review board this person will represent the Quality writing procedures and compliance Jira, software is in house Have a great team. Need good comm skills and team player. Very collaborative
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