Quality Engineer

About the role

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

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
• 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

Requirements

• 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

Preferred Qualifications

• ASQ Quality Engineering Certification
• Experience with DOE (Design of Experiments)
• Experience in Statistical Process Control (SPC)