Quality Assurance Specialist - Sturgis, MI Plant

Quality Assurance Specialist - Sturgis, MI Plant

Job Title: Quality Assurance Specialist

Location: Sturgis, MI

Employment Type: Full-time

Seniority Level: Entry level

Job Function: Quality Assurance

• Identify all batch nonconformances for final audit/review and initiate appropriate actions.
• Issue finished product shipping releases for conforming material goods in a timely manner.
• Maintain and improve guidance documents, work orders, forms, procedures, etc., supporting the Quality Systems Department.
• Ensure all documentation complies with Abbott standards and regulatory agencies before release.
• Collaborate with Senior Project Leader, Quality Engineer, or Manager to resolve quality issues.
• Address documentation concerns with plant management.
• Implement and maintain the effectiveness of the quality system; support Quality and Compliance Management for plant regulatory compliance.
• Participate in regulatory audits and assessments.
• Provide backup assistance in new product introduction (NPI) activities and support staff as needed.
• Develop master work orders, plant procedures, and deviations supporting projects and new processes.
• Provide excellent customer service to production teams while meeting compliance standards (FDA, OSHA, Abbott policies).

• Bachelor’s degree or equivalent work experience.
• Minimum two years relevant experience in Quality Assurance, Manufacturing, or Engineering.
• Effective communication with cross‑functional teams (Engineering, Manufacturing, R&D, Logistics, Plant Management).
• Knowledge of plant processes to identify causes of product quality issues and concerns during launches.
• Ability to apply knowledge to solve product quality problems.
• Sound technical judgment for audit‑able conclusions.
• Self‑driven, able to work independently with minimal supervision and meet project deadlines.
• Good working knowledge of Low Acid Food Regulations, Infant Formula Regulations, corporate and division policies, plant procedures, and governmental regulations related to manufacturing and distribution.

• Degree in Engineering or Food Science.

• Competitive compensation, incentives, and retirement plan.
• Health care and well‑being programs (medical, dental, vision, wellness, occupational health).
• Paid vacation and holiday schedule.
• Tuition assistance and reimbursement.
• 401(k) with company match.
• Retiree healthcare program.

Base pay: $61,300.00 – $.