Support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Engineer located in Libertyville, IL.
Reporting to the Quality Manager, the Quality Engineer is responsible for providing quality engineering support within new product introduction and sustaining manufacturing.
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
- 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.
The experience we’re looking to add to our team:
- 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
- ASQ Quality Engineering Certification (preferred)
- Experience with DOE (Design of Experiments) (preferred))
- Experience in Statistical process control (SPC)(preferred)
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
Is Sponsorship Available?
NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We 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 application process. Please email [email protected] and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).Skills Required
- Bachelor's degree in engineering or equivalent experience
- 6 years experience in the Medical Device industry
- Proven skills in metrology and precision measurement
- Automated processes experience
- Strong verbal and written communication skills
- Knowledge of 21CFR820 and ISO13485
- ASQ Quality Engineering Certification
- Experience with Design of Experiments
- Experience in Statistical process control
Flex Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Flex and has not been reviewed or approved by Flex.
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Healthcare Strength — Health, dental, and vision coverage begin on day one with options for dependents, alongside disability, life, mental‑health resources, and fertility/adoption and gender transition support. Plan choice and wellness programs indicate a robust healthcare offering.
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Leave & Time Off Breadth — Paid holidays, paid sick time, company‑wide shutdown days, and in some cases unlimited PTO point to extensive time‑off provisions. Flexible and hybrid work arrangements in certain teams further support work‑life balance.
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Strong & Reliable Incentives — Quarterly bonus checks and performance bonuses supplement base pay, and some roles can earn overtime at 1.5x. These elements strengthen the reliability of cash incentives.
Flex Insights
What We Do
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