Quality Engineer

Title: Quality Engineer - Design & Compliance

Location: Des Plaines, Illinois (100% On-Site)

Duration: 12 Month

Shift: 8:00 AM - 5:00 PM

Job Summary

The Quality Engineer / Quality Assurance Professional will be responsible for supporting cross-functional teams through changes to on-market product design and manufacturing processes. Additionally, the candidate may provide support for other design and compliance projects within the division.

General Responsibilities

• Provide solutions to a wide range of difficult problems, ensuring they are compliant, innovative, thorough, practical, and aligned with organizational objectives.
• Serve as the QA team member on cross-functional project teams.
• Interact effectively with employees, managers, and cross-functional peers.
• Communicate confidently and effectively with management, peers, and key stakeholders.

Design Control Responsibilities

• Guide and influence on-market product cross-functional teams through design, validation, and regulatory compliance.
• Ensure robust product performance aligned with customer requirements.
• Assess manufacturing process changes and their impact on products.
• Perform quality test case reviews for software changes.
• Formulate appropriate reasons and justifications for changes, including assessment of crucial parameters and impacted systems/products.
• Demonstrate a thorough understanding of the design control lifecycle, including Design inputs, Verification, Validation, Commercialization
• Knowledge of application of IVDR standards to the design process is a plus.

Quality System Responsibilities

• Maintain and ensure compliance with the quality system appropriate for the unit-specific medical device(s) designed or manufactured.
• Demonstrate knowledge of and compliance with site-level policies and procedures.

Education & Experience

• Bachelor’s degree in Life Science, Engineering, or a closely related discipline.
• Minimum of 5 years of experience in Quality or a related field (diagnostic quality, technical area, etc.).
• Less experience may be acceptable with an advanced degree.
• Preferred experience in the healthcare industry.
• Preferred experience with IVDR products, instrument systems, and associated software.

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.