Quality Engineer

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.

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
• Advanced computer skills, including statistical analysis, and data analysis
• 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
• Experience with Molding Manufacture process
• ASQ Quality Engineering Certification (preferred)
• Experience with DOE (Design of Experiments) (preferred))
• Experience in Statistical process control (SPC)(preferred)