Manager - Quality

Position Summary:

Industry 4.0 digital transformation projects

Key Responsibilities:

1. Develop, implement, and sustain quality standards

   to enhance in-process, supplier, and final product quality; proactively identify quality issues and recommend corrective actions.

2. Analyze rejections and defects

   using statistical and analytical tools; implement effective countermeasures to eliminate root causes and prevent recurrence.

3. Lead and execute Industry 4.0 digitalization projects

   , enabling machine and process connectivity to enhance traceability, quality monitoring, and process control.

4. Establish and maintain a robust Quality Management System (QMS)

   in alignment with corporate standards, ISO 9001:2015, regulatory requirements, and industry best practices.

5. Oversee document control, change management, and supplier quality processes

   , including supplier audits, development, and performance monitoring.

6. Conduct thorough root cause analysis and CAPA implementation

   for non-conformances, with a focus on long-term resolution and continuous improvement.

7. Design and manage an effective internal audit program

   , ensuring team competence through regular training and adherence to quality standards.

8. Execute validation master plans

   for new and existing equipment, manufacturing processes, sterilization methods, and test protocols, ensuring compliance and reliability.

9. Ensure adherence to cleanroom practices

   and quality protocols, promoting a culture of accountability and zero defects across all operational teams.

10. Monitor and evaluate process changes

    , perform statistical process control studies, interface with customers on quality matters, and lead 8D problem-solving processes.

Requirements:

• Strong working knowledge of

  ISO 9001:2015

  , quality management principles, and regulatory frameworks.
• Proficiency in quality tools and methodologies including

  7 QC tools

  ,

  8D analysis

  ,

  Root Cause Analysis

  , and

  CAPA

  .
• Experience with digital quality systems and Industry 4.0 concepts is highly desirable.
  
• Excellent analytical, leadership, and communication skills, with a proactive and results-driven mindset.