Quality Engineer - (Chicago, IL)
About The Position
Join a leading medical device contract manufacturing company, located in Chicago, IL specializing in precision-engineered products. Oberg Medical is committed to quality, innovation, and compliance with the highest industry standards. If you are a results-driven Quality Engineer looking to make an impact, we want to hear from you! Who we want on our team: Our ideal Quality Engineer candidate will have a strong understanding of industry standards. In the Quality Engineer role, the candidate will also have the ability to analyze data, interpret quality metrics, and identify trends. This is a mid-level position that is responsible for ensuring compliance with regulatory requirements, improving quality processes, and supporting production.
Requirements
- Experience working in the Quality field, preferably as a Quality Engineer in a regulated environment and/or a four-year college degree.
- Experience working in one of the following - ISO9001, AS9100, or ISO13485.
- Experience with First Articles, FMEA, and/or PPAP’s is required.
- Strong working knowledge of statistical techniques and software, ie. Minitab
- Must be able to communicate effectively, both written and oral.
- Must be a U.S. citizen or be able to comply with U.S. export regulations.
- Must be able to travel domestically and internationally.
- Must be able to wear personal protection equipment, such as earplugs, safety glasses and safety shoes.
Nice To Haves
- Experience with precision measurement equipment is preferred.
Responsibilities
- Develop and write inspection criteria/methods/reports, FMEA studies/reports, FAI submittal reports, Gage R&R’s, and PPAP reports on a customer-by-customer basis.
- Update QMS departmental procedures in accordance with the quality management systems (ISO9001, AS9100, ISO13485, and 21 CFR Part 820).
- Develop and update process validations (IQ, OQ, PQ) and technical reports for products and processes.
- Support root cause analysis of customer concerns and product nonconformities, as well as the development and implementation of corrective actions.
- Collaborate with quality engineering, manufacturing, program management, and customers to support manufacturing.
- Perform supplier audits as needed.
- Other related duties as assigned.
Benefits
- Competitive Pay ($90,000 to $110,000 based on experience)
- Medical, Dental and Vision Insurance (no premiums paid)
- Medical benefit opt-out with Reimbursement option.
- Health Savings Account (HSA)
- Short-Term & Long-Term Disability (company paid, no contribution)
- Death Benefit
- 401K Retirement Plan (with 4% employer match)
- Employer Profit Sharing program
- Quarterly Bonus Program (based on company performance)
- Paid Time Off (earning up to 5 weeks)
- 9 Paid Holidays
- Temperature-Controlled Work Environment
- Career Growth Opportunities
- Air conditioned, temperature-controlled environment
- Clean, bright, and modern facilities
- High focus on family, work-life balance
- Collaborative and safety-focused work environment
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
