POSITION SUMMARY The incumbent in this position is responsible, under VP level supervision, for leading, supporting and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on design control, risk management, post-market surveillance, CAPA, complaints, auditing, supplier/manufacturing management, system validation, NCM/MRB, change control, document control and training. This position will also support other areas of the Quality Assurance department and additional tasks determined by management. ESSENTIAL DUTIES & RESPONSIBILITIES - Lead the planning, design, preparation, execution, reporting, and analysis of design verification and validation efforts to approve equipment, systems, processes, and software used in the testing, processing, manufacturing, storing, and distribution of products.
- Support the creation and implementation of corporate policies and procedures relating to quality, project management, process development, and FDA/ISO compliance.
- Manage and maintain risk management files for multiple devices ensuring risk activities occur as required.
- Coordinate and/or lead Post-Market Surveillance activities.
- Oversee the Corrective / Preventive Action (CAPA), Change Control and NCM/MRB systems.
- Complete evaluations, reporting, and resolution of product complaints.
- Generate annual Audit Plan; manage, schedule, perform and report on internal and supplier audits. Maintain Approved Supplier List.
- Lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design, manufacturing quality and compliance to QSR/ISO requirements.
- Provide guidance to management on tools, techniques and systems for quality assurance, compliance, and continuous quality improvement.
- Assist in training company employees on the principles of Quality and other QMS elements.
- Provide Quality Metrics compilation and reporting.
- Support Document Control and Training Record management.
- Completes special projects as assigned.
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