At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives. Job Summary JOB SUMMARY:
This position, Quality Engineer, Manufacturing, located in Buffalo Grove IL which reports to a Quality Engineering Manager is assigned to a “Customer Focus Team (CFT)” consisting of Program Management, Operations, and Engineering resources responsible for the daily activities that ensure product has been manufactured to specifications and has been distributed within specifications. The Quality Engineer will be specifically responsible for the following:
- Lead process risk assessment (e.g…pFMEA, FTA, etc…) throughout its lifecycle.
- Lead nonconformance, product related CAPA, and customer complaint investigations.
- Lead creation and update of inspection plans.
- Lead Test Method Validation.
- Lead decision making thru application of statistical methods.
- Support update of process and equipment work instructions.
- Support identification and execution of process improvements.
WHAT A TYPICAL DAY LOOKS LIKE:
- 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 activities and process improvements.
- Management of 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 THE TEAM:
- 4 years experience working within the Medical device industry
- Demonstrated experience with area of responsibility defined in the summary section of this job description
- Documented 21CFR820, ISO13485 and ISO14971 training.
- Bachelor of Science Degree – Engineering discipline required.
- Preferred - Experience with ERP systems.
- Preferred - ASQ Certified
WHAT YOU'LL RECEIVE FOR THE GREAT WORK YOU PROVIDE:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
Job Category Quality
Is Sponsorship Available?NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the recruitment process. Please advise us of any accommodations you may need by e-mailing: email@example.com.
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