Quality Engineer

Flex•Libertyville, IL

35d

About The Position

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. Job Summary 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 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.

Requirements

6 years of quality engineer experince
3+ years of medical device experince (21CFR820, ISO13485 and ISO14971)

Nice To Haves

ASQ Quality Engineering Certification (preferred)
Experience with Molding Manufacture process
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 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
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.