Quality Engineer II
Viant•Wheeling, IL
•Onsite
About The Position
As a Quality Engineer II, you will provide hands-on quality engineering support directly on the manufacturing floor for medical device operations. This role requires a strong presence in the production environment, partnering closely with operators, supervisors, and manufacturing engineers to resolve real-time quality issues, support inspection activities, and ensure adherence to product specifications and regulatory requirements. The ideal candidate is a practical, detail-oriented engineer with strong experience in measurement and inspection techniques, who is comfortable working side-by-side with production teams to troubleshoot issues, answer quality-related questions, and drive immediate containment and long-term corrective actions.
Requirements
- Bachelor’s degree in Engineering or related field or 7–10 years of relevant quality engineering experience in a regulated industry
- 3–5+ years of experience in a regulated manufacturing environment (medical device preferred; aerospace, automotive, or precision manufacturing acceptable)
- Strong hands-on experience providing daily support on the manufacturing floor, including operator interaction and real-time troubleshooting
- Proven experience with nonconformance management (NCRs), including dispositioning and follow-up for effectiveness
- Hands-on experience with measurement and inspection equipment, such as: Calipers, micrometers, height gauges, Optical comparators, Coordinate Measuring Machines (CMM)
- Ability to guide and support operators on inspection techniques and acceptance criteria
- Experience with process validation (IQ/OQ/PQ) and capability studies
- Working knowledge of applicable quality and regulatory standards, such as: FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP / QSR.
- Strong understanding of quality engineering tools: Root cause analysis / Statistical methods and process capability
- Ability to read and interpret engineering drawings, including GD&T
- Strong communication skills and ability to collaborate cross-functionally
- Proficiency in Microsoft Office and Minitab
Nice To Haves
- Experience in metals, machining, or precision manufacturing environments
- Advanced experience with metrology and automated inspection systems, including: CMM programming (e.g., PC-DMIS, Calypso)
- Experience with SPC and quality data systems (e.g., InfinityQS)
- Knowledge of Measurement System Analysis (MSA) / Gage R&R
- Experience owning or leading CAPA and complaint investigations, including technical writing and customer communication
- Working knowledge of CAD tools (e.g., SolidWorks) for evaluation and analysis
- Demonstrated ability to work independently, be proactive, and drive results in a fast-paced manufacturing environment
Responsibilities
- Provide day-to-day quality support on the manufacturing floor, partnering directly with operators and supervisors to resolve quality issues in real time
- Act as a first point of contact for quality-related questions from manufacturing associates, providing guidance on inspection methods, acceptance criteria, and product requirements
- Perform and support hands-on inspection and troubleshooting using measurement equipment (e.g., calipers, micrometers, height gauges, optical comparators, CMMs)
- Support line clearances, in-process inspections, and real-time disposition of nonconforming material
- Monitor manufacturing processes for assigned products, ensuring compliance with Device Master Record (DMR) requirements and accurate completion of Device History Records (DHRs)
- Provide guidance on deviations, waivers, and product acceptance decisions, ensuring compliance with regulatory and quality system requirements
- Own and drive nonconformance (NCR) activities, including investigation, disposition, root cause analysis, and follow-up for effectiveness
- Lead and support root cause investigations on the shop floor, using structured problem-solving methodologies
- Partner with Manufacturing Engineering to troubleshoot processes, improve yields, and implement corrective actions
- Develop and improve inspection techniques, methods, and procedures to ensure product integrity and compliance to specifications
- Write, review, and implement incoming, in-process, and final inspection procedures
- Support and/or lead process validations (IQ/OQ/PQ) and capability studies, working closely with cross-functional teams
- Apply statistical quality tools (e.g., SPC, Cpk, DOE, hypothesis testing) to assess and improve process capability
- Review and provide input on engineering changes, including drawings, BOMs, control plans, FMEAs, and specifications
- Contribute to risk management activities (e.g., risk analysis, FMEA updates)
- Support internal and external audits, inspections, and regulatory activities as required
- Collaborate with suppliers, engineering, and operations teams to resolve quality issues
- Own or support CAPA and complaint investigations as needed, including data analysis, technical writing, and implementation of corrective actions
Benefits
- market competitive compensation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
