New employees are eligible for the following benefits effective date of hire!Medical, dental, and vision benefitsCompany-paid life insurance and disability benefitsGenerous Paid time off and 10 paid Holidays401k Plan with Company MatchTuition Reimbursement MAIN PURPOSE OF JOB:Quality Assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Sr. Quality Engineer will be expected to provide support to Operations, interact with Customers and provide support for Engineering, Quality Systems and Process Engineering. This position will be integral in meeting the Quality Management System requirements. In requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Production Control, Supplier Management and other appropriate procedures for a variety of medical devices from concept through market introduction. MAIN JOB RESPONSIBILITIESLeadership Exhibits the Viant Medical Values (Teamwork, Customer Oriented, Be Agile, Integrity, Own It, Servant Leadership)Provide Quality Engineering direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective mannerLead implementation of continuous improvement projects or as subject matter expert for SPC, FMEA, and process validationLead and provide Project Management support as neededOversees (With Supervisor Input) Quality Engineering Technician Development and Training to support Value StreamManage and Suggest Continuous Improvement project/strategies (Based on Site/Business Needs or Metrics) and report plans/updates during Project Governance and Site Management ReviewsFunctional ExecutionMaintain company compliance with FDA Quality Systems Regulations and ISO 13485 standardsActively participates (Often Leading) in external/internal audits, management review and other activities covered under Viant Medical Quality Manual, Policies and ProceduresCompiles and writes training material and conducts training sessions on quality control activitiesDirects development maintenance of internal/external standards relative to Impact for SiteDevelop and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fieldsDevise sampling procedures, Measurement forms, and instructions for recording, evaluating and reporting quality and sustaining product dataPerforms measurement systems analysis to evaluate test and inspection equipmentLeads disposition of discrepant material and devises process to assess product quality and investigate Root causeLeads Correction/Corrective Action assists in the resolution of complex problems (Where Applicable)ComplianceProvide customer related quality and regulatory inquiries supportDirect support for FDA and ISO inspections and registrationAdheres to Viant Values and suitably represents Viant’s best interests during Customer engagements and AuditsComplies with all safety and quality requirementsSupports Viant supply chain activities and assist with ensuring procedures are compliant to applicable sections of FDA quality system regulation and ISO 13485 regulationSpecializationFDA quality system regulation and ISO 13485 regulationsTechnical (Individual Contributor)Lead Technical Contribution to Overall Risk Based Approval Process for supplier approvals and Process Qualifications. Inclusive of qualification of new/revised items, suppliers or manufacturing processes and controlsPerforms other functions as required or duties as assignedPOSITION REQUIREMENTSKnowledge/Education:BS degree in engineering, a technical or scientific discipline; or with exception, CQE certifications / 5 plus years experienceQuality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plusJob Experience:5-10 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibilityExperience with FDA and ISO 13485 Certification inspections is a plus3 years plus Project management Experience, preference supervising diverse teamSkills/Competencies:Positive teamwork attitudeExcellent internal and external customer service skillsGood problem solving skillsUnderstanding of Lean Manufacturing philosophiesStrong written and verbal communication skillsAbility to work well independently and with fellow team membersAttention to detail and organization skillsComputer skills with proficiency in Microsoft Outlook and Microsoft Office, Minitab preferred, ExcelPhysical Requirements:Excellent vision and hand-eye coordinationOccasional periods of bending, lifting, and standingOccasionally required to lift up to 50 lbsMust be able and willing to wear personal protective equipment as required including:Protective eyewearProtective gowning (Safety Shoes covers, Apron, Hairnet, gloves)