Abbott

Senior Quality Assurance Specialist

Abbott

full-time

Posted on:

Location Type: Hybrid

Location: Abbott Park • Illinois • Texas • United States

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Salary

💰 $78,000 - $156,000 per year

Job Level

Senior

About the role

  • Support internal and external audits to ensure successful audit outcomes, including pre-audit preparations, audit logistics during, and post-audit follow-ups
  • Support Audit Readiness activities, including training staff /guidance in preparation of audits
  • Support compliance gap mitigation activities through identification of risks to the division and drives cross functional resolutions to address compliance gaps.
  • Generates and verifies quality system metrics at defined intervals
  • Promotes awareness and understanding of quality & compliance within the division.
  • Provide training to the division to increase compliance awareness
  • Participate in compliance initiatives and other assigned projects

Requirements

  • Bachelors Degree or an equivalent combination of education and work experience.
  • Minimum 3 years experience Quality Assurance, International Auditing, Quality Compliance Management, or related experience.
  • Minimum 5 years Medical Device / Pharma.
  • Experience supporting audits
  • Diagnostics product knowledge
  • Knowledge of Quality System regulations and standards (e.g., ISO 9001, ISO 13485, IVDR)
  • Experience with Power BI is a plus.
  • Able to demonstrate excellent interpersonal skills, influence others on improvements and actions, and increase compliance awareness across groups.
Benefits
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssuranceInternational AuditingQuality Compliance ManagementISO 9001ISO 13485IVDRaudit supportquality system metricscompliance gap mitigationdiagnostics product knowledge
Soft Skills
interpersonal skillsinfluencetrainingcompliance awarenesscross functional resolution