Quality Systems Section Lead - Queretaro Site (Santiago de Querétaro)

Quality Systems Section Lead – Querétaro Site

Responsible for developing, establishing, and maintaining Quality Management System programs, policies, processes, procedures, training materials, and controls to enhance performance and quality of products and demonstrate conformance to established standards and agency regulations.

Responsibilities

• Provide overall Quality Systems leadership including: direction of the personnel and activities of the team members.
• Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge.
• Aggressively identify opportunities to apply, continuously improve, and redefine Quality Management System and controls for all the product-related processes in accordance with all applicable quality regulations, US 21 CFR 820 (QSR), ISO *****, EU MDR, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide influential leadership with International sites to drive proactive quality system improvements.
• Represent Quality Systems as required in support of cross-functional projects.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• In coordination with the divisional training function, oversee, develop and provide training to divisional personnel on Quality Management System topic training.
• Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Provide guidance, leadership and organizational support for Product Development projects.
• Provide management and development of the Quality Systems staff.
• Be an effective member of the cross-functional organization to foster continuous quality compliance, cost, and predictive measures improvements.
• Liaison with Corporate General Quality organization on QMS initiatives.
• Maintain effective Quality Data Metrics and drive and execute activities to resolve decreases in performance.
• Administers the CAPA System elements, Quality Management Review and Quality Data Review for the site.
• Leads the coordination of the internal and external audits/inspections preparation and participate and or support during internal/external audits/inspections, as required.

Qualifications

• Bachelor's degree: Engineering, Science or related technical field.
• Experience in Quality roles with extensive experience with Domestic and International regulatory requirements and regulating bodies.
• Demonstrated organizational influence to include compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
• Solid knowledge and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO *****.
• Experience managing Quality Management Reviews, CAPA process and internal and external audits.
• At least 4 years ability to travel to support domestic and international manufacturing sites (up to 15%).
• 7+ years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• FDA Class II or Class III medical device experience.
• Lead Auditor/Auditor Certification preferred.

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