Supplier Quality Engineer - Intermediate

Title: Supplier Quality Engineer

Location: Lake Forest, IL

Duration: 12 months (100% Onsite)

Main Purpose of Role:

Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. Supporting supplier quality activities for injection molding (plastic) part used in manufacturing of Reagent Kits.

Responsibility:

• General
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Define project goals and milestones; ensure timely project completion.
• Provide solutions to a wide range of complex problems that are compliant, innovative, practical, and aligned with organizational objectives.
• Lead projects with cross-functional or broader scope as needed.
• Communicate confidently and effectively with management, peers, and key stakeholders.
• Provide guidance and training to other professionals and technicians; may oversee QA professionals and/or contractors.

Quality System Compliance:

• Demonstrate understanding of applicable industry standards and regulatory requirements.
• Ensure compliance with site-level, divisional, and corporate policies and procedures.
• Maintain the effectiveness of the Quality System, including subsystems and key processes, by promptly addressing noncompliance issues.

Risk Management:

• Evaluate product safety and efficacy; identify and escalate risk-based issues.
• Create and review risk management documentation to reduce or eliminate risks.
• Author and maintain risk control documentation; analyze, evaluate, and control risk decisions following established practices.

Complaint Evaluation:

• Investigate complex complaints with minimal management oversight.
• Provide compliant, thorough, and practical solutions that align with organizational goals.
• Ensure compliant documentation in all areas of responsibility.

Design Control / Documentation & Change Control:

• Develop sound rationale and justification for proposed changes.
• Identify critical parameters associated with change and represent the site as a Subject Matter Expert (SME) or Process Community Member.

Quality Engineering:

• Apply solid understanding of Quality System elements throughout the product lifecycle—from concept to launch.
• Lead quality discussions across departments and external suppliers with minimal oversight.

Validation:

• Serve as a Subject Matter Expert (SME) for at least one Validation Subsystem.
• Ensure compliant documentation and perform validation-related tasks under general direction.
• Recommend and implement practical solutions; make decisions with both short- and long-term impact.

Education & Qualification:

• Minimum: Bachelor’s Degree in Life Science, Engineering, or a closely related discipline.
• Minimum: 8–10 years of experience in Quality or a related field.
• Preferred: Experience in the medical device or pharmaceutical industry.
• Candidates with less experience may be considered if holding an advanced degree.
• Proven record of successfully completing projects and driving positive compliance outcomes.

Top 5 Skills / Requirements:

1. Engineering Degree (required)
2. Nonconformance Investigation Experience
3. Validation Experience
4. Ability to Troubleshoot Quality Issues
5. Experience Working with Cross-Functional Teams

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

 Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs