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 LinkedIn.

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, 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.

Preferred Qualifications:

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. We offer market competitive compensation. Potential salary range for this role is $85k-$100k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.