Senior Quality Engineer

Organization
ClickDX
Job Location
San Jose, CA
Job Description

Click Diagnostics is an early stage biotech startup that is looking to hire a Senior Quality Engineer to its QA team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the Director of Quality and Regulatory.

Scope of Position

The Staff Quality Engineer is an enthusiastic, self-motivated individual with great communication skills who can support the development, implementation, and management of the Quality Management Systems to ISO 13485 and FDA QSR. The Staff Quality Engineer will demonstrate a high level of individual responsibility and accountability. 

  • Creating, updating, reviewing and developing Quality Management System standard operating procedures and supporting work instructions per ISO 13485 and FDA QSR
  • Train personnel in requirements of Quality systems, tools, and techniques based on ISO 13485 and FDA QSR
  • Perform root cause data analysis using statistical techniques
  • Write and perform qualification, verification/validation protocols
  • Create and maintain quality metrics as they relate to Quality Systems and Operations
  • Develop and maintain Internal Audit program and schedule
  • Develop and maintain Supplier Quality program including supplier audit 
  • Review and approve Material Review Board and Change Control Board activities
Requirements
  • BS in science or engineering require;  Molecular Biology, Engineering, or related discipline a plus; MS preferred
  • Minimum 3 years of experience in FDA regulated Medical Device industry
  • Hands-on experience with Molecular Biology techniques
  • Professional certification in Quality Auditing, Quality Engineering, and/or Quality Management preferred

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