Quality Systems Engineer

Position Summary

The Quality Systems Engineer will be responsible for providing core quality business process support & administration enabling enterprise level compliance. This position is responsible for ensuring a compliant Quality Management system including analysis, development, and revision of QMS processes, performing monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. This position will be tasked with direct facilitation and administration of core business processes to include Engineering/Document Change Orders, CAPA, Management Review, Standards Library, Internal Audit, New Customer Audit, Regulatory Audit, and QMS/Regulatory Training.

Responsibilities

• Identify, develop, and maintain relevant QMS programs to promote quality awareness and ensure compliance to company policies and procedures including Engineering & Document Changes, Corrective & Preventive Action, Standards Library Administration, Internal Audit Management, Customer Audit Management, Regulatory Audit management, and Facilitating QMS & Regulatory Training Management
• Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow-up activities
• Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions
• Assist in the definition of and continuous improvement of quality system business processes compliant to requirements outlined in ISO 9001, ISO 13485, and/or FDA QSR
• Active participation in internal audits associated to ISO 9001, ISO 13485, and/or FDA QSR regulatory standards
• Technical content writer of new and/or revising procedure/policy content within scope of the quality system
• Analyze data and identify improvement opportunities
• Support audit activities such as closing out audit findings, creating audit finding reports and collaborating on determining the proper corrective and preventative actions
• Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits
• Technical contributor to initiatives associated to business intelligence reporting and dashboard design & validation, enterprise business workflow design & administration, and quality system business process automation through software based systems
• Ensure business systems are supported, maintained, and functioning to defined requirements
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing environment

Qualifications

• Bachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM certified program
• 5+ years of experience working with quality management systems in regulated environment (ISO 13485, EUMDR, FDA)
• Knowledge of quality systems, regulatory requirements, and industry standards
• Academic experience with business intelligence software tools
• Ability to consistently achieve short and long-term business results
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask
• Ability to travel up to 15%