Staff Quality Assurance Engineer

zDNU - Other Blue Ash, Ohio

1. Quality Management / Continuous Improvement (70%)
• Support Quality Management System conformance to customer, internal, ISO 13485, and any other applicable regulatory/legal requirements
• Identify and lead efforts for system improvement, increasing compliance and system effectiveness
• Create and update QMS procedures
• Attend and assist in Management Review meetings, including collection and analysis of data presented
• Collect and report out on data for QMS Status meetings
• Create system impact reports and Quality Plans to manage system changes and updates
• Cover the duties of QMS Document Coordinator when the Manager is unavailable
• Create and send regular training reports to managers
• Create materials and host company training on quality topics
• Lead the functional training program, assist training owners in schedule, execution, and follow-up
• Evaluate CAPAs for adverse events and effectiveness
• Conduct interim evaluations with CAPA owners as necessary
• Evaluate customer complaints for next steps and completeness
• Review and comment on Quality Questionnaire surveys for moderate level vendors
• Perform supplier audits as necessary
• Address notified body audit findings, and help others in the organization to address any level audit findings
• Disposition internal audit findings from finalized audit reports
• Push completion of Quality action items across the organization, helping employees when necessary
• Support the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s services
• Create and execute Software Validation documentation, both project specific and for QMS needs
2. Quality Consultant to Projects/Teams (25%)
• Work with internal project teams to develop defined risks for both the project and product
• Identify Design Control needs in collaboration with the project team
• Review, edit, and approve in-process Design Control documents
• Advise on Design Control related documents, projects, and planning
• Evaluate and report out on trends for risk data and lessons learned
3. Quality Consultant to Sales (5%)
• Attend introductory and quoting meetings to field Quality specific questions
• Review project planning information from the perspective of Quality and risk management
• Provide and review Quality time estimations in project planning
This job description is not intended to be all inclusive and the employee will also perform other reasonably related business duties as assigned by the immediate supervisor and other management as required.
• Knowledge and skills at a level normally acquired through the completion of a Bachelor’s degree in Engineering or related fields. Advanced degree not required but useful.
• Experience with Quality Management Systems within the context of medical device development

• ISO 13485 Lead Auditor Certificate
Skills/Specialized Knowledge/Abilities
• Associate’s or Bachelor’s degree in Engineering or related field
• 3- 6+ years of experience preferred
• Experience in medical device industry or other highly regulated field
• Experience driving risk management discussions
• High attention to detail in striving for excellence in processes, deliverables and execution
• Maintains rational and objective demeanor/actions when faced with s
• Proficient with Microsoft Office applications: (Word, Excel, PowerPoint, Access, Outlook)