CAPA Specialist, Operations - Sturgis, MI Plant

CAPA Specialist, Operations – Sturgis, MI Plant

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and generic medicines, serving people in more than 160 countries with 114,000 colleagues.

The CAPA Specialist progresses investigations through Abbott’s CAPA system, working closely with functional areas to determine root causes of nonconformities and ensuring corrective and preventive actions are implemented in a timely and compliant manner.

• Evaluates and progresses CAPA system activities, including effectiveness checks, raised non-conformances, potential non-conformances, and deviations as output from ADC’s Quality System.
• Facilitates the investigation process, ensuring root/potential causes are appropriate and implementing effective actions to reduce occurrence or recurrence.
• Maintains CAPA system records to ensure audit‑readiness for internal and external quality system audits.
• Ensures all CAPA‑related documentation is managed in a complete, clear, concise, and controlled manner.
• Supports a team‑effective environment by demonstrating cross‑functional support that complies with corporate and regulatory requirements.
• Supports other organizations in managing their CAPA actions, providing confidence that investigations are initiated and completed promptly and effectively.

• High School Diploma/GED and Associate’s Degree OR 2+ years’ CAPA work experience in a manufacturing plant environment.
• 2+ years of experience in a regulated, manufacturing environment.
• Ability to apply strategic and quality logic and project management skills to investigation activities.
• Good project management skills to deliver an effective service in a timely manner.
• Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
• Good written and oral communication skills to ensure effective and concise report generation and communication with staff at all levels.
• Ability to work independently.

• Knowledge of FDA Quality System Regulations.

• Career development opportunities within an international company.
• Eligibility for free medical coverage through Abbott’s Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• High‑employer‑contribution retirement savings plan.
• Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit for affordable undergraduate degrees.
• Recognition as a great place to work, highly admired by Fortune and recognized for diversity, inclusion, and support of working mothers and female executives.

Abbott is an Equal Opportunity, Military/Veteran friendly Employer, committed to employee diversity. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

The base pay for this position is $61,300.00 – $. In specific locations, the pay range may vary from the range posted.