Quality Specialist Iii
CurrentResponsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensures that deadlines are met on time and within budget. Quality interface with other departments and business or marketing partners. Work independently with minimal supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.Primary responsibilities for role:● Conducts compliance audits of more complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls.● Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes.● Serves as QA interface with limited responsibilities to other departments.● Reviews Customer Notifications and prepare, approve & submit data packages for external customers.● Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.● Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.● Assists in developing quality systems & make recommendations for improvements to existing Quality systems.● Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.● Assists in chairing meetings as appropriate such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), and other meetings.● Prepares appropriate Agendas and meeting minutes with minimal supervision.● Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.● Represents QA as an extended core team member on Core team and cross functional special project teams with minimal supervision.