Quality Engineer

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 the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Engineer located in Libertyville, IL.

Reporting to the Quality Manager, the Quality Engineer is responsible for providing quality engineering support within new product introduction and sustaining manufacturing.

What a typical day looks like:

• Lead process risk management (e.g., PFMEA) throughout its lifecycle
• Lead the evaluation and resolution of product and process nonconformances, product related CAPA and customer complaint investigations
• Lead creation and update of product inspection plans
• Lead decision making through application of statistical methods
• Support update of process and equipment work instructions and procedures
• Overall responsible for calibration specification sheets and tracking of all IPC measurement and test equipment calibration, in collaboration with the calibration department
• Perform measurement uncertainty analysis
• Support New Product Introduction with metrology planning
• Lead/Support identification and execution of process improvement efforts by identifying methods of capturing quality metrics’ data and performing appropriate analysis, to enhance manufacturing process
• Lead systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Lead process control and monitoring of CTQ parameters and specifications, to reduce/eliminate the cause of defects
• Lead and implement various process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• Participate in or lead teams in supporting quality decisions and best practices (e.g., represent the Quality function as a Core/Customer Team Member)
• Be the CFT lead for risk management.
• Provide leadership necessary to execute assigned activities as an individual contributor and facilitator.
• Align with cross-functional business partners to determine appropriate support to complete quality related activities and process improvements for sustaining manufacturing or new product introduction.
• Manage assigned activities (themselves and team members) to ensure timely completion.
• Support critical issues and investigations as needed.
  
  

The experience we’re looking to add to our team:

• Typically requires a bachelor’s degree in engineering or equivalent experience and training.
• 6 years’ experience working within the Medical Device industry, with overall working experience of minimum 6 years in Quality
• Proven skills related to metrology and precision measurement
• Automated processes experience
• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization and with customers
• Demonstrated knowledge and experience with application of 21CFR820, ISO13485 and ISO14971
• ASQ Quality Engineering Certification (preferred)
• Experience with DOE (Design of Experiments) (preferred))
• Experience in Statistical process control (SPC)(preferred)
  
  

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [e-mail] and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).