Quality Systems Engineer

About the role

Overview About Cretex Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

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
• 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
• Quality system business process automation through software based systems.
• Ensure business systems are supported, maintained, and functioning to defined requirements