Role Overview :
The Quality Specialist 3 is responsible for implementing, supporting, and sustaining elements of the quality system. The Quality Specialist 3 serves as a senior quality systems resource for ISO, EN, MDSAP, MDD, EU MDR, J-GMP and QSR requirements for the Austin, TX site.
He / she provides oversight and guidance in quality systems operations, ensuring continuous compliance to external standards / regulations and internal requirements, and assists globalization of requirements, where necessary.
The position will provide support to all elements within the Quality Management System, including but not limited to internal and external audits, CAPA, document control / records, training, and external standards monitoring.
Specifically, he / she shall :
Monitor processes and personnel to assure compliance with the QMS, DOPs and GMP requirements. Pursues resolution of issues and problems as they arise.
Responsible for internal tracking system for approval of corrective and preventive actions. Responsible for ensuring CAPA investigations are robust and that corrections and / or corrective actions are taken eliminate the non-conformance.
Responsible for identifying non-conforming events and ensuring appropriate documentation of these occurrences. If there are errors, inconsistencies, or deficiencies in CAPA documentation, he / she is responsible for interaction with the respective area owner for follow-up and correction.
Lead compliance and process improvement initiatives related to the Quality Management System.
Assist in the preparation and coordination of internal audits and external inspections to verify adherence to international / US standards and internal quality policies / procedures.
Establish and maintain successful cross-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments.
Coordinate corrective actions for issuance, review, and closure of action plans.
Assist in other quality systems responsibilities requested by management to ensure a robust and compliant Quality Management System.
Act as Quality Management representative during the absence of the Quality Systems Manager.
Position Functions :
Provide leadership, quality oversight, and decision-making for Quality Systems processes (e.g. CAPA, internal audits, external inspections, standards / regulations, training, document control, etc.
Develop and implement solutions for issues and non-conformances related to Quality Systems processes. 25 %
Lead and / or support compliance and process improvement initiatives related to the QMS. 20 %
Review, update and implement changes to procedures to ensure compliance to regulations and standards (e.g. 21 CR 820, ISO 14385, MDD, EU MDR, etc.
Provide training as necessary to support these QMS policies and procedures. Effectively support and follow policies and procedures. 15%
Assist in the preparation and coordination of internal audits and external inspections. Assist in the response resolution of resulting findings and tracking of these response commitments. 15%
Assist in the quality oversight of the CAPA process to ensure the robustness of investigations and resulting corrections / corrective actions.
Provide training to enhance investigations and knowledge of controlled document systems. Serve as the controlled document system Quality Administrator and actively interface with CAPA owners throughout the CAPA lifecycle. 15%
Maintain key quality metrics / indicators to track performance and compliance and analyze data to develop and implement improvements to streamline and improve processes and procedures.
Assist in the preparation of Quality Systems metrics for Management Review meetings. Percent of Position 5%
Assist in other responsibilities by management to ensure compliance. 5%
Bachelor's degree in science, engineering, or related discipline.
5 years of experience in quality
Ability to communicate effectively in English.