Quality Engineer II

Viant • Wheeling, IL

2d • $85,000 - $100,000 • Onsite

About The Position

As a Quality Engineer II you will provide quality engineering support for medical device manufacturing operations. This role is highly technical and hands-on, partnering directly with production teams to troubleshoot quality issues, manage nonconformances, and ensure ongoing compliance to applicable quality system and regulatory requirements. The position is focused on day-to-day value stream support and will grow to include customer quality support, CAPA ownership, and complaint handling.

Requirements

• Bachelor’s degree in engineering or related field required OR 7–10 years of experience working in a quality engineering role within a regulated industry.
• 3–5 years of experience in medical device or other regulated manufacturing environment such as aerospace, automotive, or materials processing.
• Experience in sustaining/base-business manufacturing quality role providing direct production floor support
• Experience owning nonconformance (NCR) workflows, dispositioning, and follow-up to ensure effectiveness.
• Process validation experience (IQ/OQ/PQ) and capability studies; comfort working with protocols and reports.
• Working knowledge of relevant regulations/standards (e.g., FDA 21 CFR 820, ISO 13485:2016, MDSAP, ISO 14971, QSR, MDD, TGA).
• Competence in the selection and use of quality engineering tools and techniques (e.g., root cause analysis, statistical methods, capability).
• Ability to interpret engineering drawings; print reading and GD&T.
• Strong communication skills and ability to partner with key stakeholders across production and engineering.
• Proficient in Microsoft Office and Minitab.

Nice To Haves

• Strong technical depth in metals and metal processing; hands-on inspection and measurement experience.
• Experience leading or owning CAPA activities and complaint investigations, including technical writing of investigation summaries and customer responses.
• Automated inspection and metrology programming experience (e.g., CMM programming with PC-DMIS and/or Calypso).
• Experience with SPC and quality data systems (e.g., InfinityQS).
• Working knowledge of CAD for evaluation/communication (e.g., SolidWorks).
• Demonstrated ability to work independently, be proactive, and collaborate effectively across functions.

Responsibilities

• Adhere to Viant Core Beliefs and all safety and quality requirements, including QMS, EMS, FDA regulations, company policies/operating procedures, and other applicable regulatory requirements.
• Support regulatory and agency inspections, audits, investigations, and inquiries related to the control and assessment of product design and manufacturing quality.
• Monitor manufacturing for assigned products, ensuring compliance with DMR; provide deviation/waiver guidance; and ensure complete and accurate Device History Records (DHRs) are maintained.
• Lead and implement product and process improvement methodologies.
• Review the adequacy and correctness of changes to BOMs, assembly procedures, drawings, component specifications, FMEAs, control plans, and related documentation.
• Lead the completion and maintenance of risk analyses.
• Lead the generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes for new and existing products; coordinate process validations and capability studies.
• Recommend process monitoring devices where applicable.
• Develop inspection techniques and procedures to ensure product integrity to design specifications.
• Write, approve, and implement incoming, in-process, and final inspection procedures.
• Ensure disposition of nonconforming materials meets regulatory requirements and that corrective actions are adequate to prevent recurrence.
• Communicate and interact effectively with customers.
• Lead and manage complaint investigations.
• Own CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
• Assist with product transfers.
• Work with suppliers, management, engineers, and manufacturing associates to resolve quality problems.
• Lead cross-functional efforts for capability studies and application of statistical quality control (e.g., Cpk, DOE, hypothesis testing).
• Coordinate and lead preparation of Quality Plans, including inspection, test, and gauge requirements for new product introductions.
• Provide support to other quality engineers.
• Perform other duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees