Quality Engineer (Medical Device) - NPI & CAPA Leader

Flex; Libertyville (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Flex is seeking a Quality Engineer to be based in Libertyville, IL, and provide quality engineering support during new product introduction and sustaining manufacturing. The role reports to the Quality Manager and leads risk management, CAPA investigations, and inspection planning.

Responsibilities include applying statistical methods, maintaining calibration programs, and driving Six Sigma/Lean improvements while collaborating with cross-functional teams to ensure product quality and regulatory

Qualifications

• Typically requires a bachelor’s degree in engineering or equivalent experience and training.
• 6 years’ experience in the Medical Device industry, with overall quality experience.
• Proven skills related to metrology and precision measurement.
• Automated processes experience.
• Strong verbal and written communication skills.
• Knowledge of 21 CFR 820, ISO 13485 and ISO 14971.
• ASQ Quality Engineering Certification (preferred).
• Experience with DOE (Design of Experiments) (preferred).
• Experience in Statistical Process Control (SPC) (preferred).

Responsibilities

• Lead process risk management (e.g., PFMEA) throughout its lifecycle.
• Lead evaluation and resolution of product/process nonconformances, CAPA and customer complaint investigations.
• Lead creation and update of product inspection plans.
• Lead decision making through application of statistical methods.
• Support calibration specs and tracking of IPC measurement/test equipment calibration.
• Perform measurement uncertainty analysis.
• Support New Product Introduction with metrology planning.
• Lead/Support process improvement through data-driven quality metrics.
• Lead systematic problem‑solving to identify and resolve quality issues.
• Lead process control/monitoring of CTQ parameters to reduce defects.
• Lead Six Sigma and Lean manufacturing efforts.
• Participate in or lead Core/Customer Teams for quality decisions.
• Be the CFT lead for risk management.
• Provide leadership to complete activities and coordinate with cross-functional partners.
• Manage assigned activities to ensure timely completion.
• Support critical issues and investigations.

Skills

Process risk management

CAPA investigations

Statistical methods

Metrology

Six Sigma

Lean Manufacturing

Education

Bachelor's degree in engineering or equivalent

ASQ Quality Engineering Certification (preferred)

Tools

DOE

SPC

Job description

Flex is seeking a Quality Engineer to be based in Libertyville, IL, and provide quality engineering support during new product introduction and sustaining manufacturing. The role reports to the Quality Manager and leads risk management, CAPA investigations, and inspection planning.

Responsibilities include applying statistical methods, maintaining calibration programs, and driving Six Sigma/Lean improvements while collaborating with cross-functional teams to ensure product quality and regulatory