Engineering - Quality Assurance Engineering/Control)

Quality Assurance - Sr. Quality Engineer - Manufacturing About the Site:Our Wheeling facility combines precision machining and assembly capabilities to deliver high-quality medical device components and finished products.Benefits:Medical, Dental, and Vision benefits, effective date of hire136 Hours PTO (prorated based on hire date) & 10 paid HolidaysCompany-paid life insurance401k plan Pet InsuranceHome OwnershipTuition ReimbursementAbout the RoleWe are seeking a highly experienced and motivated Senior Quality Engineer to join our team. This role is critical in ensuring product quality and regulatory compliance throughout the design and manufacturing process. The ideal candidate will bring deep expertise in quality systems, process improvement, and cross-functional collaboration within a regulated industry, preferably medical devices.What you’ll do: Key ResponsibilitiesAdhere to company Core Beliefs and all safety and quality requirements, including, but not limited to company Quality Management System (QMS); Environmental, Health & Safety; company policies, procedures, and work instructions; and other relevant regulatory requirements.Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.Monitor manufacturing of assigned products, ensuring compliance with DMR and quality system requirements, and ensure complete and correct Device History Records are maintained.Identify, prioritize, and implement product and process improvement initiatives.Review the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.Generate and lead the completion of protocols and reports for product, process, and test method validations.Partner with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Ensure that the disposition of non-conforming materials comply with all relevant requirements and ensure that appropriate corrective actions are implemented to prevent recurrence.Lead complaint investigations and manage appropriate remediation activities.Review quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses.Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc.Provide technical support and direct the work of Quality Inspectors, Quality Technicians, Training Specialists, and/or other Quality Engineers as needed.QualificationsEducation:Bachelor’s degree in Engineering (Mechanical Engineering preferred) or a related discipline.Experience:Minimum 7+ years of Quality Assurance experience in a regulated manufacturing environment, preferably medical devices or other regulated industry. Certifications (Preferred):CQE, CRE, CQA, Six Sigma Green or Black BeltSkills & CompetenciesStrong knowledge of root cause analysis, DOE, statistics, lean manufacturing, risk management, and Six Sigma methodologies.Proficient in Microsoft Office and Minitab.Familiarity with metals processing and Toyota Production System is a plus.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. 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.