Quality Assurance Specialist

1 day ago


Santa Clara, California, United States ATR International Full time
Job Title: Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team at ATR International. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities:
  • Drive preparation of KPI dashboards and maintain a pulse on formal RA management review and internal metrics.
  • Manage strategic programs for RA audit preparedness, including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
  • Support quality system integration for acquisitions and new product introductions.
  • Identify and implement system and/or systemic processes.
  • Support tracking and maintenance of regulatory post-approval commitments.
  • Drive quality system process improvement initiatives, including but not limited to:
    • Establishing audit support for integration products.
    • Improving and maintaining the quality system procedures (e.g., change management).
    • Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.
    • Participating in audit backrooms, and
    • Participating in RA projects.
Requirements:
  • Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations.
  • Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.
Skills:
  • Independent
  • Troubleshooting
  • Critical thinker
  • Ability to drive a problem through resolution and implement mitigations.
  • Ability to handle multiple streams simultaneously.
Benefits:
  • MEC/ACP Medical
  • Voluntary Dental, Vision, Life, Supplemental Income

-401k (must meet requirements)

-Sick leave as required by state/county



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