Quality Manager

I. Position Summary

The Quality Manager, India, supporting distribution and supplier management, is a critical leadership role within embecta’s operations in India. This position ensures robust quality systems are in place for managing supplier relationships, overseeing distribution processes, and maintaining regulatory compliance within the medical device manufacturing industry. The Quality Manager will drive alignment with embecta’s global quality standards while adapting processes to meet local regulatory requirements and market needs. This role is pivotal in safeguarding the integrity of the supply chain, optimizing distribution operations, and building strong partnerships with suppliers to uphold embecta’s commitment to delivering life-enhancing medical devices.

II. Key Responsibilities

• Supplier Quality Management:
• Develop and implement supplier quality management processes, including qualification, audits, and performance monitoring.
• Ensure suppliers meet regulatory and embecta quality requirements, with timely corrective and preventive actions for nonconformance issues.
• Lead supplier performance reviews and drive continuous improvement initiatives to enhance product quality and reliability.

• Distribution Quality Management:

• Oversee distribution processes to ensure compliance with embecta’s quality standards and regulatory requirements.
• Monitor quality metrics across the supply chain, identifying risks and implementing mitigation strategies.
• Ensure proper documentation and validation of distribution processes, including transportation, storage, and inventory handling.
• Regulatory Compliance:
• Maintain adherence to local and global regulatory requirements, including ISO standards (ISO 13485, ISO 14971) and applicable Indian regulations.
• Collaborate with cross-functional teams to ensure regulatory readiness for audits and inspections related to supplier and distribution quality.

• Risk Management:

• Lead risk assessment processes for supplier and distribution activities, identifying and mitigating potential risks to quality and compliance.
• Ensure risk management practices align with ISO 14971 standards and embecta’s global requirements.
• Cross-Functional Collaboration:
• Work closely with Procurement, Logistics, Manufacturing, and Regulatory Affairs teams to align quality initiatives with operational objectives.
• Act as the main point of contact for quality-related matters in supplier management and distribution.
• Team Leadership and Training:
• Mentor and develop a team of quality professionals, fostering a culture of accountability and continuous improvement.
• Deliver training programs for suppliers and internal teams to ensure consistent quality practices.

Ⅲ. POSITION REQUIREMENTS

• Bachelor’s degree in in a Science/Engineering discipline.
• A minimum of 8 years’ technical/engineering experience or a combination of equivalent education and experience.
• Fluent in English, reading, writing, speaking