Site Quality Leader

Job Profile Summary

The Quality Assurance Manager is responsible for orchestrating operational objectives and plans, monitoring KPIs, resolving complex quality assurance issues, managing supplier processes, overseeing product recalls, maintaining supplier quality, and leading talent management within the organization to drive productivity and alignment with company goals. The role monitors operational KPIs to evaluate success, actively participates in policy development with potential organizational impact and creatively resolves complex issues aligned with company goals. The role owns supplier qualification processes, aids in audits and regulatory compliance, and monitors supplier quality metrics. The role manages talent, driving employee selection, performance management, compensation, and career development for effective operational management.

Job Responsibilities

• Establishes operational objectives and work plans, delegates assignments to subordinates to ensure smooth execution and efficient distribution of tasks within the organization and fosters collaboration and productivity while aligning with overarching goals.
• Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization.
• Utilizes wide-ranging experience and professional expertise, creatively resolves complex issues aligned with company objectives, distinguished by additional specialized knowledge and recognized as an expert in the field.
• Guides the review and approval of finished products manufactured for and by the company, manages all inspections and inquiries regarding the operation of manufacturing sites and collaborates with relevant company groups to ensure compliance with company standards, regulations and approved manufacturing process specifications.
• Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Oversees material and spare part qualification, coordinates enhancements in supplier processes for critical-to-quality parameters, ensures implementation of supplier process control plans with control limits and tolerances, finalizes updates to the approved supplier list and ensures compliance with release requirements for company materials and products.
• Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes.
• Directs product recall procedures, ensures swift and efficient resolution in accordance with company policies and regulatory standards, and oversees all aspects of the recall process to maintain compliance and uphold consumer safety.
• Owns supplier qualification, audits, and assessments processes, supports in external and internal audits, aids in regulatory compliance gap closure, monitors supplier quality metrics, agreements, and records, and participates in supplier quality-related communication and feedback.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.

Education

Bachelor's / Master's Degree in Quality Management, Supply Chain Management, Engineering, Science or equivalent.

Work Experience

Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination or Warehouse Operations or equivalent.

Certifications

• Quality Assurance (QA)
• Quality Management Systems (QMS)
• Continuous Improvement
• Quality Control Inspection
• CAPA Methodologies
• Quality Management Procedures and Methodologies
• Supplier Quality Management
• People Management
• Risk Management
• Strategic Planning
• Regulatory Compliance
• KPI Management
• Budget Management
• Business Acumen

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