Sr Quality Engineer

at Illumina (view profile)
Location Madison, WI
Date Posted June 25, 2019
Category Biotechnology
Job Type Full-time
Address 5602 Research Park Blvd Suite 200

Description

Position Summary:

We are seeking a talented, driven and experienced QMS professional to join our dynamic team.  This role will partner cross-functionally to influence and ensure compliance to applicable standards, regulations as well as to the Illumina Quality Management System.

Responsibilities:

Strong background in Quality Management Systems (emphasis in Nonconforming Product, CAPA and Change Management).

  • Nonconforming Product:
    • Advise, evaluate, approve and verify non-conforming product and process (NCRs) dispositions meet requirements of the NC process, are correctly documented, implemented and closed in a timely manner
  • CAPA:
    • Advise, evaluate, perform and assist in CAPA process to ensure investigations and implementation of corrections/corrective actions are appropriate, clearly documented and effective
  • Audit Program:
    • Ability to serve as subject matter expert in support of internal and external audits
    • Participate in investigations and ensure audit findings, associated risks, recommendations and outcomes are appropriate, clearly documented and completed in a timely manner
  • Quality Management Review:
    • Ability to serve as subject matter expert in support Quality Management Review
    • Ability to trend, analyze, and report on quality data in order to improve products and processes
    • Ability to develop recommendations based on data analysis
  • Ensure areas of responsibility meet FDA 21 CFR 820 and ISO 13485 requirements
  • Partner cross-functionally in order to ensure awareness and compliance to procedures, specifications, ISO requirements and any applicable regulations
  • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely manner
  • Authority to assess and release final product
  • Other activities as assigned

 Experience:

  • 5+ years’ experience in quality management systems.
  • Strong knowledge and experience with quality regulations and standards as well as experience applying them (e.g., 21 CFR 820, ISO 13485, ISO 14971).
  • Highly effective communication, facilitation, coaching, and negotiation skills including ability to present and participate in executive presentations.
  • Self-starter, strong work ethic, strong organizational skills, critical thinking.
  • Excellent attention to detail and accuracy, well organized and able to work independently and in teams.
  • Adaptable to fast-paced, dynamic work environment with shifting demands
  • Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.

 Education:

  • BS/BA or equivalent in Engineering, Biological/Life Sciences, Chemistry or related field required.

Click here to learn more & apply today. 

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