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Abbott

Makes heart devices, glucose sensors and lab tests

Quality Manager

Validation, Compliance & Quality SystemsUpdated on Nov 9
Full-timePōkeno, New ZealandNo salary listed

About the Job

Requirements

  • A bachelor's degree in a scientific or technical discipline, or an equivalent combination of education and work experience, is required.
  • Certification specified by Abbott must be obtained and maintained.
  • Strong judgment, problem-solving, and decision-making skills are required.
  • Effective written and verbal communication, strong interpersonal ability, and consulting ability are required.
  • The candidate must be well-organized and tech-savvy.
  • Excellent technical and regulatory local knowledge related to the role is required.

Responsibilities

  • Lead and maintain the site's Quality Management System (QMS), ensuring compliance with Risk Management Programme (RMP) requirements, FSSC 22000 standards, customer requirements, and applicable legislation.
  • Act as the RMP Programme Owner, managing RMP amendments, exception reporting, product dispositions, regulatory submissions, and communications with the Ministry for Primary Industries (MPI) and other regulatory authorities.
  • Lead the HACCP Programme and oversee Prerequisite Programme (PRP) governance, ensuring food safety hazards, controls, and programme reviews remain effective and compliant.
  • Manage traceability and recall preparedness, including oversight of traceability systems, mock recalls, and compliance verification activities.
  • Lead food safety governance and performance review processes, including Food Safety Meetings, compliance reporting, risk assessment, and continuous improvement initiatives.
  • Serve as the primary contact for customer, certification, and regulatory audits, ensuring audit readiness, facilitation, and timely close-out.
  • Provide day-to-day leadership, coaching, and oversight of Compliance Specialists.
  • Drive continuous improvement of food safety and quality systems by managing food safety risks, shut-down and start-up control plans, and compliance trends.
  • Meet the requirements of the RMP and FSSC 22000 Food Safety Management System by complying with applicable food safety, quality, regulatory, and company procedures to achieve business objectives and customer requirements.
  • Comply with relevant company Occupational Health, Safety and Environmental policies, procedures, and work practices to prevent or minimise accidental exposures to self, colleagues, and the environment.
  • Promote excellence in quality and customer focus at Abbott.
  • Uphold the Abbott Code of Business Conduct.
  • Live Abbott's Pioneering, Achieving, Caring, and Enduring values.

Desired Qualifications

  • Demonstrated experience in dairy nutritional and/or infant formula manufacturing, operating within an RMP, is strongly preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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