Sr Quality Design Engineer

Sr Quality Design Engineer

16 Jan 2024
California, Sanmateo, 94401 Sanmateo USA

Sr Quality Design Engineer

Vacancy expired!

Position:

Sr Quality Design Engineer
Location:

San Mateo, CA
Duration:

Full time

Job Description:
  • Minimum of three years of experience in a design assurance role supporting medical devices that are FDA Class II or Class III.
  • Working knowledge of FDA design control deliverables (21 CFR 820), IEC 62304, AAMI TIR45, ISO 14971, and Cybersecurity.
  • Working knowledge of Agile Software Development methodologies and associated development tools (e.g. Jira, Jama).
  • Familiarity with the role of Human Factors/Usability in the software development lifecycle.
    ASQ (e.g. CQE, CRE, or CSQE) certifications or other software quality certificates are desirable.
  • Experience with supporting regulatory audits and FDA inspections is a plus.
  • Excellent interpersonal, verbal, and written communication skills.

Sumit Madne

IT-SCIENT Tel: ext 116 Fax Email: Web: itscient.com

Job Details

  • ID
    JC8238960
  • State
  • City
  • Job type
    Permanent
  • Salary
    Depends on Experience
  • Hiring Company
    IT-SCIENT
  • Date
    2021-01-13
  • Deadline
    2021-03-14
  • Category

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