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Please click here to be redirected to the internal career site.Job Description
The Sr. Quality Engineer will be based in Buffalo Grove, IL. This position will support the molding quality engineering projects as well as improvements related to applicable processes.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do:
- Develop and initiate standards and methods for inspection, testing and evaluation
- Devise sampling procedures and design and develop forms and instructions for recording, evaluating and reporting quality and reliability data.
- Develop and implement methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.
- Direct workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
- Compile and write training material and conduct training sessions on quality control activities.
- Support Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
- Assure data availability and integrity for all quality related data. Consolidate and report quality results.
- Initiate corrective action requests as needed and track to satisfactory completion.
- Assist with development and implementation of quality audits.
- Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
- Design and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Investigate customer complaints.
- Establish program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.
- Approve product, process and equipment qualification.
Here is some of what you'll need (required):
- Bachelor's degree in engineering or related degree
- Minimum 6 years of Quality experience in the Medical Device industry
- Strong experience writing and developing inspection plans and visual defect references
- Knowledge of Process Validation for medical device industry (IQ/OQ/PQ)
- Working knowledge of CAPA (corrective and preventative action) and FMEA
- Demonstrated knowledge of multiple functional technologies/ processes related to product manufacturing including molding
- Strong verbal, customer-facing, and written communication skills
Here are a few of our preferred experiences:
- Plastic injection molding operations knowledge
- Demonstrated knowledge of compliance to ISO 13485 and FDA 21CFR 820
Here are a few examples of what you'll get for the great work you provide:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices 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. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: email@example.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.
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