About the position
The QA Manager / Director will be responsible for managing all activities of the Quality Assurance department and maintaining the Company's Quality Management System in accordance with applicable international standards and regulatory requirements. Managing the QA team and sharing supervisory responsibility of one employee in Logistics and carrying out supervisory responsibilities in accordance with AVS' policies and applicable laws. Furthermore: 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, Document Control, Medical Device Post-Market Vigilance and Complaint Handling and Evaluation, Risk Management processes (ISO 13485 and 14971 Standards), 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 and act as liaison with Santen Ltd. and Santen Inc. Quality, Regulatory, and R&D groups where requested. Actively participate in the AVS management team and provide leadership in Quality for the Production and R&D departments. Interact, 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 with a customer serving face. Other duties may be assigned.
Responsibilities
- Manage all activities of the Quality Assurance department.
- Maintain the Company's Quality Management System in accordance with applicable international standards and regulatory requirements.
- Establish and maintain the AVS Quality Management System (QMS).
- Ensure 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, Document Control, Medical Device Post-Market Vigilance and Complaint Handling and Evaluation, Risk Management processes.
- Support improvements to the QMS and integration of processes into Santen corporate systems.
- Support Santen Global Teams for improvement of Global Medical Device policies, standard operating procedures, and systems.
- Establish and maintain product inspection, acceptance or rejection and release activities.
- Assist in the development of domestic or international regulatory filings.
- Act as liaison with Santen Ltd. and Santen Inc. Quality, Regulatory, and R&D groups.
- Participate in the AVS management team and provide leadership in Quality for the Production and R&D departments.
- Create and maintain quality, laboratory, or service agreements with vendors, suppliers, subcontractors, and consultants.
Requirements
- Bachelor's degree (B.A. /Sc.) from four-year college or university.
- At least 7 years’ related experience in QA in a medical device manufacturing environment.
- Knowledge of the ISO 13485 Quality Management Standard & FDA medical device regulations.
- Must be detail-oriented and able to multi-task.
- 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.
Benefits
- Salary range for QA Manager position is $110,000 - $130,000 depending on experience.
- Salary range for QA Director position is $120,000 - $170,000 depending on experience.
