JOB TITLE: Quality Manager
REPORTS TO: Director, Quality Assurance & Regulatory Affairs
JOB DESCRIPTION: The Quality Manager will provide critical support to the quality and regulatory function at Premier Dental Products Company. This role works in partnership with the Quality Assurance & Regulatory Affairs department and senior management, product development, manufacturing, operations, marketing/sales and others, to ensure the highest possible quality outcomes. This role will develop and implement an effective, robust quality management system (QMS), processes and methods in alignment with regulatory and ISO requirements.
• Assist in the development and deployment of quality policies, objectives and plans that align and support the corporate strategic business goals
• Submit post market notices such as medical device reports, field safety corrective actions, and recall notices to regulatory agencies or notified bodies
• Manage CAPA process and ensure effective coordination of investigations, root cause analysis, corrective and preventive actions, and effectiveness check according to timelines
• Provide guidance on handling of nonconforming products and ensure further actions resulting of nonconforming product is complete
• Handle Supplier Management function including audits, SCARs, quality agreements, etc.
• Ensure actions from changes to products or processes are communicated internally through the organization and externally to any suppliers
• Hold reviewer/approver responsibility for CoAs and CoCs for customer requests
• Prepare for and assist and participate in notified body and regulatory body audits
• Monitor and lead/conduct internal audits of the quality management system processes for compliance, effectiveness, and continued alignment with applicable regulatory and statutory requirements.
• Assist in the updating or creation of SOPS, Work Instructions, and Forms
• Manage and assign responsibilities for completing post market surveillance activities to schedule
• Assist in computer software validation activities and ensure the validation plan is followed
• Facilitate training and educate employees in regulatory and quality requirement as needed
• Maintain a contemporary knowledge of current industry trends, standards and methodologies as they relate to regulatory and quality systems and management.
• Apply a risk based approach to all applicable elements of the Quality Management System
• Perform other duties as required
• 3+ years of Quality System experience in a medical device company
• Bachelor’s Degree in relevant field
• Proficiency in Microsoft Office programs such as Microsoft Word, Excel, Powerpoint
• Must possess excellent interpersonal, communication (written and verbal), problem solving and negotiating skills
• Excellent organizational, prioritization and time management skills
• Experience in CAPA and SCAR programs, including effective root cause investigation, handling corrective and preventive action planning and execution and verification of effectiveness techniques.
• Experience in training others in quality management systems
• ISO 13485:2016 Auditor Certification Preferred
• Experience handling audits (notified body, internal, suppliers, etc.)
• Experience with quality tools and process improvement techniques
• Knowledge of and experience working with ISO 13485:2016, and the FDA regulations (21 CFR §210 and 820), EU MDD/MDR, MSDAP.
• Familiarity with Drug Quality Security Act, Sunshine Act, Drug Quality Security Act, lot control, and other applicable regulations
Contact Karen Giannone if interested, or if you need more information.