Quality Assurance Specialist

hace 4 semanas


Caimito Barrio, Puerto Rico Abbott A tiempo completo
About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team in Alameda, CA. As a Quality Assurance Specialist, you will be responsible for conducting internal quality audits to assess compliance to regulatory requirements, participating in and supporting external regulatory audits, and maintaining timely closure of audit cycles.

Key Responsibilities
  • Lead/support assigned divisional internal/clinical/supplier audits to maintain timely closure of the audit cycles
  • Support Audit Readiness activities for external audits, including training staff and providing guidance in preparation for external audits
  • Support compliance gap management activities, including identifying risks to the business and resolving compliance gaps
  • Assist management of near miss program
  • Track regulations and industry standards revisions and evaluate their impact on the business
Requirements
  • AS or BS degree or combination of appropriate education and experience
  • 5 years of experience in the medical device industry and 5 years auditing per ISO and/or FDA standards
  • Excellent writing skills
  • Experience working in a broader enterprise/cross division business unit model preferred
  • Ability to work in a highly matrixed and geographically diverse business environment
What We Offer
  • Career development with an international company
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO
  • Excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit

Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary range of $73,600.00 - $147,200.00, depending on location. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.



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