Quality System Manager Leader

3 weeks ago


Westfield, Indiana, United States Abbott Laboratories Full time
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.

Our Mission

We restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

Job Summary

We are seeking a Quality System & Regulatory Compliance Manager to join our team at our Westfield, IN location in the Structural Heart Medical Device Division.

Key Responsibilities
  • Provide guidance, direction, and strategic leadership in quality and regulatory compliance matters.
  • Establish and implement an internal audit program to effectively assess and report on the site's status relative to defined quality system requirements.
  • Plan activities needed to assess the status of the quality system and organize resources to execute the identified plan.
  • Approve documentation as dictated by procedures and report status of key quality and compliance indicators to local and divisional management.
Requirements
  • Bachelor's Degree in Chemistry, Biology, Engineering, or related science; Master's Degree preferred.
  • Good communications and negotiation skills to assure the resolution of compliance issues.
  • High degree of initiative, decision making, and responsibility to perform efficiently with minimal supervision.
  • Strong regulatory compliance and technical background, statistical knowledge, and analytical skills.
What We Offer

We offer a competitive salary range of $95,000.00 – $190,000.00, depending on location and experience. Additional benefits include career development opportunities, comprehensive health insurance, retirement savings plan, tuition reimbursement, and education assistance programs.



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