Senior Manager, Post Market

3 weeks ago


Burlington, Massachusetts, United States Abbott Laboratories Full time
About the Role

We are seeking a highly skilled Senior Manager, Post Market to join our Quality team at Abbott Laboratories. In this role, you will be responsible for ensuring the effectiveness of our quality system, including personnel development and performance assessment. You will also provide direct and indirect supervision to professional and labor staff to ensure compliance with global regulations.

Key Responsibilities
  • Implement and maintain the effectiveness of the quality system, including complaint handling and investigation processes.
  • Identify and recruit staffing resources to support complaint handling activities and on-market support for multiple product lines.
  • Develop and implement organizational structures to achieve business objectives and QA compliance.
  • Evaluate complaints against criteria for potentially reportable events and elevate to the medical events group as necessary.
  • Champion and participate in the development of complaint handling processes and procedures.
  • Ensure customer complaints are reviewed in a timely manner and elevated to the medical events group as necessary.
  • Identify and remediate product quality issues through the corrective and preventive action system.
  • Monitor incoming complaints for increasing trends and alert management when a product issue is emerging.
  • Participate in monthly tracking and trending meetings to provide input on early trends.
Requirements
  • Bachelor's Degree in a related field, including Engineering, Life Sciences, or Medical/Clinical.
  • Minimum 8+ years' experience in Quality roles in a regulated industry.
  • Minimum 3+ years' managing/leading organizations.
  • Minimum 2+ years' complaint handling experience.
  • Substantial working knowledge of CFR 820, 803, 806, ISO 13485, and ISO 14971.
Preferred Qualifications
  • Demonstrated experience building effective organizations and leveraging teams to accomplish projects.
  • Experience with operational Lean, Six Sigma, and Continuous Improvement initiatives.
  • Experience with cardiovascular systems.
  • Advanced degree in the biomedical field.
  • Experience working in a broader enterprise/cross-division organization.
  • Working knowledge of Microsoft Office suite and statistical software.
  • Strong technical writing skills and effective communication skills.
About Abbott Laboratories

Abbott Laboratories 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.

We are committed to employee diversity and offer a range of benefits, including career development opportunities, free medical coverage, and a retirement savings plan with high employer contribution.

Join us at Abbott Laboratories and be part of a team that makes a difference in people's lives.



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