Quality Engineer II

About the site

Our Wheeling facility focuses on precision machining of metal components, supporting high-performance medical device manufacturing.

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.

• 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.

• 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…