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Flex Quality Engineer United States, Illinois 338217898
Yesterday
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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
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