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QA Specialist II (Product Complaints)- Onsite

Collabera, Alameda, CA, United States


QA Specialist II (Product Complaints) - Onsite

Join to apply for the QA Specialist II (Product Complaints) - Onsite role at Collabera .

Job Details

  • Location: Alameda, CA 94502
  • Industry: Medical Devices
  • Duration: 6 months with potential extension
  • Pay Range: $35.00/hr - $42.00/hr

Responsibilities

  • Serve as SME for complaints management, excluding manufacturing QA.
  • Handle complaints processing, evaluation, and reporting, not data entry.
  • Create and update procedures within the complaint handling system.
  • Perform CAPA, deviations, and evaluate complaints in line with regulatory guidelines.
  • Maintain documentation and records for product complaints.

Qualifications

  • Bachelor's or Master’s degree with 3-7 years of relevant experience.
  • Experience in complaints handling for regulated products, preferably medical devices.
  • Good documentation practices and ability to work independently.
  • Preferred: Medical device complaint handling, familiarity with regulations, post-market surveillance experience.

Additional Information

  • Seniority level: Entry level
  • Employment type: Contract
  • Job function: Quality Assurance
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