Quality Engineer II

About the company:

Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high-quality, life-enhancing products with the scale and expertise to bring devices to market efficiently. Learn more at Viant Medical's website or on Linked In.
About the site:
Our Wheeling facility focuses on precision machining of metal components, supporting high-performance medical device manufacturing.

About the role:

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.
What you'll do:

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.

Required Qualifications:

Minimum 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,…