Quality Assurance Quality Engineer III

Quality Assurance - Sr. Quality Engineer - ManufacturingAbout the Site:Our Wheeling facility combines precision machining and assembly capabilities to deliver high-quality medical device components and finished offer market competitive compensation. Potential salary range for this role is $95k-$115k. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. Onsite :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 youll 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 regulatory and agency inspections audits investigations and inquiries regarding the control and assessment of product design and manufacturing manufacturing of assigned products ensuring compliance with DMR and quality system requirements and ensure complete and correct Device History Records are prioritize and implement product and process improvement the adequacy and correctness of changes to Bills of Material (BOMs) Assembly Procedures Drawings Component Specification FMEAs Control Plans and lead the completion of protocols and reports for product process and test method with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where required and/or various inspection techniques and procedures to ensure product integrity to design specifications. Write and implement Incoming In-Process and Final Inspection that the disposition of non-conforming materials comply with all relevant requirements and ensure that appropriate corrective actions are implemented to prevent complaint investigations and manage appropriate remediation quality data for potential CAPAs including analyses of data and trends in complaints supplier quality nonconforming material training effectiveness and root cause with product 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 technical support and direct the work of Quality Inspectors Quality Technicians Training Specialists and/or other Quality Engineers as :Bachelors degree in Engineering (Mechanical Engineering preferred) or a related :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 in Microsoft Office and with metals processing and Toyota Production System is a interpersonal written and verbal communication ability to work independently and manage multiple success in driving continuous improvement and leading cross-functional 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 6000 associates across 24 locations worldwide we offer a unique combination of small-company service and attention with big-company resources. For more information visit 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.