Senior Quality Systems Auditor Leader

11 hours ago


Minneapolis, Minnesota, United States Abbott Laboratories Full time

About Abbott

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Abbott Laboratories is a global leader in the healthcare industry, dedicated to improving people's lives through innovative medical technologies and treatments.

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Join Our Team as a Senior Quality Systems Auditor Leader

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We are seeking an experienced professional to join our team as a Senior Quality Systems Auditor Leader. In this role, you will be responsible for implementing internal audits required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for FDA inspection preparation and support.

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About the Role

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This leadership position requires a strategic thinker who can develop and implement effective audit plans, manage teams, and drive process improvements. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and identify opportunities for improvement.

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Key Responsibilities

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  • Develop and implement internal audit plans to ensure compliance with global regulatory standards">
  • Collaborate with Abbott Medical Device Business Units for FDA inspection preparation and support">
  • Manage teams of auditors to ensure effective implementation of audit plans">
  • Drive process improvements and continuous learning within the quality systems group">
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Requirements

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To be successful in this role, you will need:

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  • Bachelor's degree in a related field or equivalent experience">
  • Minimum 6 years' experience in quality systems or a related field">
  • Prior experience in the medical device industry and/or quality systems">
  • Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing">
  • Proven track record of managing projects from initiation to completion in a timely manner">
  • Strong technical writing skills and excellent oral and written communication skills">
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Preferred Qualifications

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The ideal candidate will have:

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  • Demonstrated leadership/management skills with respect to achievement of company goals and objectives">
  • Experience working in a broader enterprise/cross-division business unit model">
  • Prior audit and management experience, preferably in Medical Devices">
  • Prior experience in the preparation and management of external inspections, preferably with FDA">
  • Ability to travel up to 25% of the time, with occasional short notice trips to support unannounced FDA inspections">
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Salary Range

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$83,000.00 - $166,000.00 per year

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Apply Now

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Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives.



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