Viant is a global medical device partner providing design, development, manufacturing, and assembly services. As a Quality Engineer II, you will provide quality engineering support for medical device manufacturing operations, partner with production teams to troubleshoot quality issues, manage nonconformances, and ensure compliance to quality system and regulatory requirements.
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 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
Benefits
- 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