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 6000 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 Medicals website or on the site:Our Wheeling facility focuses on precision machining of metal components supporting high-performance medical device 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 youll 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 regulatory and agency inspections audits investigations and inquiries related to the control and assessment of product design and manufacturing manufacturing for assigned products ensuring compliance with DMR; provide deviation/waiver guidance; and ensure complete and accurate Device History Records (DHRs) are and implement product and process improvement the adequacy and correctness of changes to BOMs assembly procedures drawings component specifications FMEAs control plans and related the completion and maintenance of risk the generation and completion of protocols and reports for test method with Manufacturing Engineers to review processes for new and existing products; coordinate process validations and capability process monitoring devices where inspection techniques and procedures to ensure product integrity to design approve and implement incoming in-process and final inspection disposition of nonconforming materials meets regulatory requirements and that corrective actions are adequate to prevent and interact effectively with and manage complaint CAPA activities including analysis of data and trends in complaints supplier quality nonconforming material training effectiveness and root cause with product with suppliers management engineers and manufacturing associates to resolve quality 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 support to other quality other duties as Qualifications:Minimum Requirements:Bachelors degree in engineering or related field required OR 710 years of experience working in a quality engineering role within a regulated industry.35 years of experience in medical device or other regulated manufacturing environment such as aerospace automotive or materials in sustaining/base-business manufacturing quality role providing direct production floor supportExperience owning nonconformance (NCR) workflows dispositioning and follow-up to ensure validation experience (IQ/OQ/PQ) and capability studies; comfort working with protocols and 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& communication skills and ability to partner with key stakeholders across production and in Microsoft Office and Qualifications:Strong technical depth in metals and metal processing; hands-on inspection and measurement leading or owning CAPA activities and complaint investigations including technical writing of investigation summaries and customer 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 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