Quality Assurance Specialist – Onsite at Abbott, Sturgis, MI
Job Summary:
Abbott Nutrition is seeking a Quality Assurance Specialist to join its dynamic team in Sturgis, Michigan. This role ensures regulatory compliance, batch audit reviews, documentation quality, and production release in one of Abbott’s premier nutrition product facilities. The ideal candidate will have a strong background in food science, engineering, or related technical fields, with working knowledge of FDA regulations, plant manufacturing processes, and product quality management.
Key Responsibilities:
Identify nonconformance issues in final batch audits and initiate appropriate corrective actions.
Issue shipping releases for conforming finished goods in a timely manner.
Maintain and enhance Quality Systems documents including work orders, forms, and procedures.
Ensure all quality documentation complies with Abbott and regulatory agency standards.
Support successful completion of regulatory audits and assessments.
Assist with development and execution of New Product Introduction (NPI) activities.
Provide guidance in the creation of master work orders, plant procedures, and deviation reports.
Communicate effectively across departments such as Engineering, Manufacturing, R&D, and Management.
Implement and uphold an effective Quality Management System ensuring plant-wide regulatory compliance.
Required Skills & Qualifications:
Bachelor’s degree in Engineering, Food Science, or a related technical field preferred.
Minimum 2 years of relevant experience in Quality Assurance, Manufacturing, or Engineering.
Strong knowledge of Low Acid Food Regulations, Infant Formula Regulations, FDA guidelines, and corporate policies.
Problem-solving skills for identifying and resolving product quality issues.
Excellent communication skills to work cross-functionally with internal teams.
Ability to work independently and manage multiple tasks efficiently.
Experience in regulatory audits and continuous quality improvement processes preferred.
Perks & Benefits:
Base salary range: $60,000 – $120,000 annually.
Free medical coverage via Health Investment Plan (HIP) PPO for qualifying employees.
Comprehensive 401(k) retirement plan with generous company match.
Tuition reimbursement and Freedom 2 Save student debt program.
Paid vacation (120 hours in the first year) plus 10 paid holidays and personal days.
Retiree healthcare program.
Onsite wellness programs and clean, temperature-controlled production areas.
Career development opportunities with a globally recognized healthcare leader.
Company Description:
Abbott is a global healthcare leader specializing in life-changing technologies across diagnostics, medical devices, nutrition, and pharmaceuticals. Serving over 160 countries, Abbott's mission is to help people live fuller, healthier lives through science-based products and innovations.
Work Mode:
On-site (Sturgis, Michigan, USA)
Call to Action:
Advance your quality assurance career with a trusted global leader in healthcare and nutrition. [Apply Now] to become part of Abbott’s dedicated QA team in Sturgis, MI, and make a meaningful impact on health and nutrition worldwide.
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