Senior Specialist, Product Quality Assurance (pqa)

Abbott

Lake Forest, IL, United States
Base: $78,000.00 – $156,000.00; bonus/equity: not ...
Fda 21 cfr 803 and 806 compliance
Iso 13485 quality system standards
Medical device report (mdr) writing
The Senior Specialist will conduct post-market surveillance activities to ensure product safety and regulatory compliance in the Core Lab Diagnostics Division

Job Summary

  • The Senior Specialist will conduct post-market surveillance activities to ensure product safety and regulatory compliance in the Core Lab Diagnostics Division.
  • Employees qualify for free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.
  • This role requires investigating complaints, writing Medical Device Reports, and collaborating with engineering and laboratory staff to assess patient safety impacts.

Matching Summary

The Senior Specialist will conduct post-market surveillance activities to ensure product safety and regulatory compliance in the Core Lab Diagnostics Division.

Salary

Base: $78,000.00 – $156,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • FDA 21 CFR 803 and 806 compliance
  • ISO 13485 quality system standards
  • Medical Device Report (MDR) writing
  • Complaint investigation and data gathering
  • Risk assessment and evaluation execution

Nice-to-have

  • Strong understanding of business concepts
  • Experience with cross-functional collaboration
  • Ability to apply clinical knowledge to products

Key Requirements

  • Bachelor's degree in related field or equivalent experience
  • Minimum 6 years of related work experience
  • Masters Degree preferred

Work Rights

Not specified

Tailored Resume

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