Senior Quality Assurance Specialist – Abbott, Abbott Park, IL
Job Summary
Abbott, a global leader in healthcare and diagnostics, is hiring a Senior Quality Assurance Specialist for its Abbott Park, Illinois location. This role focuses on ensuring regulatory compliance, risk management, and maintaining the effectiveness of quality systems to support innovative diagnostic solutions. Ideal for professionals with experience in medical devices, IVDR, or healthcare quality assurance.
Key Responsibilities
Define project goals and ensure timely completion of quality-related projects.
Deliver compliant, innovative, and practical solutions for complex quality challenges.
Lead and participate in cross-functional projects influencing quality assurance processes.
Train, guide, and oversee QA professionals and contractors.
Ensure adherence to FDA and ISO quality system standards and Abbott corporate policies.
Conduct risk evaluations and develop risk control documentation.
Investigate and resolve complex product complaints with minimal oversight.
Drive design control, change control, and documentation processes.
Act as Subject Matter Expert (SME) in at least one validation subsystem.
Required Skills & Qualifications
Apprenticeship or Bachelor’s degree in Life Science, Engineering, or related field.
Minimum 5 years of experience in quality assurance or related field (less with advanced degree).
Strong understanding of healthcare, diagnostics, or medical device industries.
Proven track record of completing quality assurance projects successfully.
Knowledge of risk management principles, complaint investigation, and validation practices.
Excellent communication, problem-solving, and documentation skills.
Preferred: IVDR regulatory experience.
Perks & Benefits
Competitive salary range: $85,300 – $170,700 per year.
Comprehensive health care (medical, dental, vision, wellness).
Paid time off and occupational health programs.
401(k) retirement plan with generous company match.
Tuition assistance and career development programs.
Onboarding training and continuous skill enhancement.
Stability and growth within a globally recognized healthcare company.
Company Description
Abbott is a world-renowned healthcare innovator with a rich history in diagnostics, medical devices, nutrition, and pharmaceuticals. Serving over 160 countries, Abbott provides life-changing technologies that help millions live fuller, healthier lives.
Work Mode
On-site — Abbott Park, Illinois, United States.
Call to Action
Ready to shape the future of diagnostic healthcare with Abbott’s quality assurance team? Apply now to embark on a career that makes a real difference!
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