JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

• Directly supervise a team of CAPA Investigators and CAPA analysts and lead an extended team with members from multiple functional areas across the sites in the performance of investigations for multiple product lines and systems deemed critical to the success and financial performance of the sites. 
• Establishes Training material for members of the CAPA program and ensures training strategies maximize performance and compliance with required regulatory requirements & expectations. 

What You'll Do:

• Establishes and drives strategies to achieve site and division quality and compliance goals with regards to the CAPA investigations and the CAPA metrics program.
• This includes the establishment of Quality System policies and procedures as needed to ensure compliance.
• Directly supervises a team of CAPA Investigators and CAPA analysts and leads an extended team of qualified investigators with members from multiple functional areas across the site/division in the performance of non-conformance investigations and corrective actions.
• Reviews CAPA investigations performed by qualified staff to ensure that documents are thorough, complete and timely.
• Manage the resolution confirmation process & works with event owners and division management to ensure CAPA quality, timeliness and other compliance parameters.
• Establishes Training material and approaches for members of the CAPA program and ensures training strategies maximize performance and compliance with worldwide regulatory requirements & expectations.
• Verifies product safety and efficacy have been evaluated and issues related to safety/patient results are elevated for risk evaluation.
• Ensures the execution of the Executive Management Review Program and that appropriate metrics are identified, compiled, and reviewed by a cross-functional team in order to identify adverse trends and the drivers for those trends.
• Division Liaison to the Corporate Quality organization in the maintenance of the global system for Exception reporting and CAPA and for the Quality Systems Data Warehouse (QSDW).
• Authorizes changes to CAPA Management Systems.
• Serves as the primary CAPA system contact during regulatory inspections and Corporate AQR audits.
• Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, quality and regulatory.
• You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences.  These events may take place on an evening and/or weekend.

Requirements:

• Bachelor’s degree in engineering, science, quality, or related discipline (or equivalent experience).

• Minimum 8 years of experience in Quality, Manufacturing, and/or CAPA management within regulated manufacturing environments.

• Strong working knowledge of CAPA systems, root cause analysis, and risk‑based management.

• Demonstrates strong judgment, problem-solving, and decision-making skills

• Communicates effectively (written and verbal) with strong interpersonal and consulting ability

• Well-organized and tech-savvy,

• Excellent technical and regulatory local knowledge as it relates to the role

• Proven project management and execution skills.

• Clear written and verbal communication skills.

Location:

This position is based in Waikato District > Pokeno.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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