CAPA Specialist – Quality Assurance | Abbott | Sturgis, MI (On-site)
Job Summary:
Abbott Nutrition is hiring a CAPA Specialist to join its Quality Assurance team in Sturgis, Michigan. This role is vital for managing the Corrective and Preventive Action (CAPA) system, ensuring thorough investigation, root cause analysis, and effective resolution of quality issues in a regulated environment. The specialist will collaborate with cross-functional teams to maintain audit readiness and regulatory compliance while driving continuous improvement across manufacturing processes.
Key Responsibilities:
Progress investigations and activities in the CAPA system for nonconformances and deviations.
Facilitate root cause analysis and implement corrective/preventive actions (CA/PAs) ensuring compliance with FDA QSR and ISO13485 standards.
Ensure timely and complete documentation of CAPA activities, including effectiveness checks and closure.
Maintain CAPA records to support internal and external audits.
Collaborate with cross-functional teams to resolve quality issues impacting manufacturing processes and product releases.
Drive system improvements for sustainability, simplicity, and regulatory alignment.
Provide quality insights and recommendations to prevent potential compliance risks.
Ensure continuous improvement in CAPA system usability and audit readiness.
Required Skills & Qualifications:
Bachelor’s Degree (preferred) in Engineering, Science, or related technical field.
Minimum 2 years’ experience in a regulated industry, quality assurance, or investigation processes.
Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 preferred.
Strong problem-solving and project management skills.
Excellent written and verbal communication skills for reporting and stakeholder interaction.
High attention to detail and ability to manage documentation to audit standards.
Ability to work independently and cross-functionally in a team environment.
Perks & Benefits:
Competitive base salary range of $60,000.00 – $120,000.00 annually.
Free medical coverage under the Health Investment Plan (HIP) PPO (subject to qualification).
Excellent 401(k) retirement plan with high employer contributions.
Tuition reimbursement and Freedom 2 Save student debt program.
FreeU education benefit for pursuing a bachelor’s degree.
Paid vacation, holidays, and personal days.
Global recognition as a top employer for diversity, inclusion, and career development.
Company Description:
Abbott is a global healthcare leader dedicated to developing life-changing products in diagnostics, medical devices, nutrition, and pharmaceuticals. With a presence in over 160 countries, Abbott continues to improve the lives of millions worldwide through innovation and quality-focused solutions.
Work Mode:
On-site (Sturgis, Michigan, USA)
Call to Action:
Advance your quality assurance career by joining Abbott’s Nutrition Division. Apply today and make an impact on global health and nutrition products.
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