Quality Engineer I

Title: Quality Engineer I

Location: Des Plaines, Illinois

Duration: 6 Month Assignment

Position Summary:

We are seeking a highly motivated Quality Engineer I to support cross-functional teams in managing changes to on-market product designs and manufacturing processes. This role will also assist with other design and compliance initiatives across the division. The ideal candidate will bring analytical problem-solving skills and a solid understanding of quality systems, regulatory compliance, and product lifecycle management.

Key Responsibilities:

• Act as the Quality Assurance representative on cross-functional project teams, ensuring project deliverables meet internal and external quality standards.
• Lead and support the implementation of design and manufacturing process changes for existing products, ensuring regulatory compliance and risk mitigation.
• Provide guidance on design control activities including design inputs, verification, validation, and design transfer.
• Evaluate the impact of manufacturing changes on product performance, quality, and regulatory status.
• Support the application of IVDR standards (a plus) within the design process and ensure alignment with regulatory expectations.
• Collaborate with teams across Manufacturing, Information Management, R&D, QA Operations, and Product Performance to ensure adherence to LifeScan software development procedures and industry regulations.
• Review and approve software development lifecycle (SDLC) deliverables for compliance and quality.
• Lead hazard analysis activities and contribute to the development of SOPs and work instructions tailored to specific software development needs.
• Provide training on software development procedures as needed.
• Occasionally develop and execute test protocols and reports.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• Experience:
• Minimum of 5 years of professional experience in quality assurance, regulatory compliance, or a related technical field (diagnostics, assay development/support, etc.).
• Candidates with a Master’s degree and less experience may be considered.
• Preferred background in the healthcare or medical device industry.
• Experience in assay development or diagnostic quality is a plus.
• Strong knowledge of design controls, quality systems (QMS), and relevant regulatory requirements.
• Excellent communication skills with the ability to collaborate across functional teams and influence decision-making.

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.