The Director of Quality and Compliance is responsible for leading, planning, executing, and standardizing the NPD and related LCM policies, processes, and standards at the HTC site. This position oversees the product quality assurance program to prevent or eliminate defects in new and existing products, ensuring the release of safe, effective, and high-quality products compliant with all regulatory requirements.

This role is reporting to Senior Director Quality & Compliance.

Key Responsibilities:

Quality and Compliance Management:

• Lead the Quality and Compliance department and ensure compliance with all regulatory requirements and standards.
• Collaborate with business and functional leaders to drive risk mitigation, proactive actions, and continuous improvement.
• Set strategies and goals for HTC Quality and Compliance functions in alignment with applicable regulations.
• Ensure effective implementation of quality compliance policies related to global medical device, safety, and environmental laws.

Quality Services:

• Establish and manage organizations supporting business processes and compliance, including quality risk management, design assurance, internal audits, corrective and preventive actions, records management, and document control.
• Oversee complaint management, medical device reporting, and quality data management across disciplines.

Regulatory Interface:

• Serve as a point of contact for Regulatory Authorities regarding actions and inspections.
• Maintain up-to-date knowledge of international regulations and standards and ensure adherence through the Quality Manual.

Documentation and Customer Complaints:

• Ensure compliance with documentation procedures and control, producing end-user documentation for HTC-developed products.
• Manage customer complaints, initiate corrective actions, analyze trends, and interact with NPD project teams to address service needs throughout the project lifecycle.

Quality Engineering:

• Oversee Quality Engineering functions, including supplier qualification, product release, field actions, and complaint resolution activities.
• Foster collaboration among NPD departments to promote design excellence and quality improvements in new and existing products.
• Define and monitor metrics for Quality Engineering, QS, and Compliance Departments to drive product and system quality improvements.

Software Quality Assurance:

• Ensure software quality assurance processes and deliverables comply with process validation and verification standards.

Management Representation:

• Act as a Management Representative or deputy, ensuring the quality management system’s effectiveness and promoting regulatory awareness within the organization.

Leadership and Communication:

• Communicate business-related issues and opportunities to higher management levels.
• Ensure compliance with company guidelines related to health, safety, and environmental practices.
• Develop and coach team members to achieve functional strategies and objectives.

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