JOB DESCRIPTION

The Team Lead Quality Engineering plays a critical role in optimizing product quality and manufacturing efficiency by applying advanced statistical methods to solve complex process challenges. You are responsible for a team of 10 quality engineers, promoting a culture of continuous learning in New Product Introduction (NPI) and seamless product transfers.
A key responsibility is leading in-depth investigations into non-conformances, driving the implementation of effective CAPA measures to enhance process reliability ensuring full compliance with industry standards (ISO13485). The role also spearheads initiatives to strengthen supplier quality, collaborating across functions to resolve intricate technical issues.

• Handles in-depth investigations into nonconformances, determining root causes and directing the implementation of robust corrective and preventive actions (CAPA), while monitoring effectiveness and overseeing Non-Conformances (NC) and Quality Notifications (QN) at an advanced level.
• Conducts assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Ensures the coordination of activities within a department, potentially through subordinate supervisors, ensuring accountability for results, including costs, methods, and staffing, demonstrates good working relationships with suppliers and direct shop floor production engineering sustaining experience, and previous experience of participation in several New Product Introductions (NPIs).
• Possesses complete knowledge of products/services, often leads a cooperative effort to implement robust CAPA measures with a focus on effectiveness and frequently interacts with and functional peer groups on matters between functional areas or customers.
• Resolves quality non-conformities with R&D, Supplier Engineering and production team for non-conformities inflow reduction.
• Implements strategic policies while selecting methods and evaluation criteria for obtaining results, manages subordinate staff members, establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
• Guides the execution of intricate validation protocols, coordinating complex production activities to support validation efforts and ensure rigorous validation outcomes aligned with regulatory requirements.
• Participates in audits, interprets findings and discusses comprehensive, strategic quality reports with stakeholders, highlighting key achievements, emerging trends, and actionable insights to drive continuous improvement initiatives and ensure regulatory compliance.
• Develops and delivers specialized training programs on advanced quality standards, methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an expert proficiency level.
• Networks with key contacts outside own area of expertise and maintain strategic partnerships with external/internal stakeholders.