Flex Quality Engineer 

United States, Illinois 

338217898

Job Summary

Reporting to thethe

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.
• Min 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
• ASQ Quality Engineering Certification (prefer)
• Experience with DOE (Design of Experiments) (prefer)
• Experience in Statistical process control (SPC)( prefer)

What you'll receive for the great work you provide:

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Pay Range (Applicable to Illinois) $86,200.00 USD - $118,500.00 USD Annual