Job Details

PRIMARY PURPOSE OF POSITION:

• Manage all activities of the Quality Assurance department and maintain the Company's Quality Management System in accordance with applicable international standards and regulatory requirements.
• Manages QA team and shared supervisory responsibility of one employee in Logistics.
• Carries out supervisory responsibilities in accordance with AVS' policies and applicable laws.

MAJOR DUTIES OF POSITION:

• Establish and maintain the AVS Quality Management System (QMS), ensuring ongoing compliance with applicable domestic and international quality assurance for AVS' medical device design, manufacture, and distribution.
• Manage the Company's QMS, including QA Inspection, DocumentControl, Medical Device Post-Market Vigilance and Complaint Handling and Evaluation, Risk Management processes, Corrective/Preventive Action, Environmental Monitoring, and Equipment Calibration processes.
• Support applicable improvements to the QMS and appropriate integration of processes into Santen corporate systems.
• Support Santen Global Teams for improvement of Global Medical Device policies, standard operating procedures, and systems to the extent possible.
• Establish and maintain product inspection, acceptance or rejection and release activities including ensuring there are adequate numbers of qualified employees in these Departments.
• Assist in the development of domestic or international regulatory filings.
• Act as Management Representative to the Company's Notified Body.
• Act as liaison with Santen Ltd. and Santen Inc. Quality, Regulatory, and R&D groups where requested.
• Establish product specifications based on design inputs from the R&D Group and associated data.
• Establish and maintain the Company's EC Declarations of Conformity.
• Actively participate in the AVS management team.
• Provide leadership in Quality for the Production and R&D departments.
• Obtain and maintain appropriate QMS registration
• Provide information requested by Regulatory counterparts in Santen Regulatory Affairs to support regulatory filings.
• Along with Regulatory personnel, is responsible for Post-Market Vigilance activities including complaint handlingand root-cause troubleshooting; evaluation and submission of incident or adverse event reports, advisory and product field safety notices, recalls and reporting.
• Establish and maintain the Company's Technical Files andDevice History Records.
• Report on the functioning of the quality system by providing periodic analysis of process data to the management team for review during formal Quality Management Review meetings in accordance with both the Company's requirements and the corporate template.
• Ensure device labeling requirements, including UDI where applicable, are satisfied.
• Establish and maintain a system for acquisition, review, and analysis of updates to applicable international standards used to demonstrate conformity of the Company's devices.
• Ensure CA/PA, internal audits, and environmental monitoring system works effectively.
• Establish and maintain a risk management system compliant with the ISO 13485 and 14971 Standards (as revised).
• Create and maintain quality, laboratory, or service agreements (as appropriate) with vendors, suppliers, subcontractors, and consultants as defined by established procedures and applicable regulations or standards.
• Create and maintain a system for storage and easy retrieval of employee Training Records and means of comparison to current job requirements.
• Ensure employees are familiar with the Company's Quality Policy and requirements of applicable Quality System Regulations, current Good Manufacturing Practices, Good Documentation Practices, and similar.
• Other duties may be assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor's degree (B.A. /Sc.) from four-year college or university
• At least 7years' related experience in QA/RA in a medical device manufacturing environment
• Able to calculate figures and apply concepts of basic mathematics
• Knowledge of the FDA medical device regulations & ISO 13485 Quality Management Standard
• Must be detailed oriented and able to multi-task
• Possess solid computer skills
• Must be proficient in:
• Excel - create and work with spreadsheets
• Word - format professional correspondence
• PowerPoint - create meeting presentations
• Outlook - email & maintain company calendars
• EFP/MFP Manufacturing software
• Excellent verbal and written communication skills
• Must be dependable and flexible
• Must be a team player and have experience providing support for numerous internal customers