Job Posted On: Monday, December 3, 2018
Act as a Management Representative for external and internal Auditors. Complete corrective actions for Audits following Quality Management Systems. Update Quality Manual as needed with new standards and enforce QMS at the company.
• Manage, mentor and train employees in our quality systems procedures, and general regulatory compliance requirements.
• Manage compliance and regulatory requirements for a global market environment, including regular review of regulatory and standards to ensure compliance with most updated requirements.
• Write and update Quality Systems documentation to meet all applicable FDA Quality SystemsRegulations, European Medical Device Directives as well as applicable standards includingISO13485 QualitySystems.
• Function as the Management Representative in all Quality Systems affairs, including management Review Meetings, nonconforming reports, complaints and Corrective Action andPreventive actions (CAPA).
• Approval of quality documentation, specifications and technical files as required by ISO13485:2016.
• Oversee all quality systems audit planning, preparation and response activities including internal audits, ISO registration and surveillance audits, and any applicable regulatory inspections.
• Oversee system for establishing requirements and tracking of employee training of documents.
• Serves asQualityManagement reviewer for all product andlabelingspecificationsandDesignHistory File and/or Technical file content.
• Monitoring of the maintenance and calibration of equipment.
• Bachelor's degree in Engineering or in Natural Sciences, Chemistry or another applicable field of study required
• Completed a QMS training system "ISO 9001 or ISO13485"
Experience and Skills
• Experience with ISO and/or FDA compliance in Medical Device Distribution
• Experience with FDA Auditors and Other ExternalAuditors
• Proficient in Microsoft Office and ability to navigate and utilize customized inventory software and web-based and stand-alone applications
• Must be able to effectively and respectfully communicate and collaborate with employee at all levels and with external Auditors.
• Must be able to handle Compliance Training as needed within the organization.
IOS promote equal treatment for all employees or potential employees irrespective of race, creed, color, sexual orientation, nationality, ethnic origins, religion, age, gender or material status; and that this is a managed in such a way that the organization complies with and goes beyond the Equal Opportunities and Code of Practice.