Quality and Operations Transformation Manager

This position based in Singapore will have the responsibility to lead the design, implement and stabilize a robust QMS for ELAPAC to then transition toward a full Operations Management role. The first phase will ensure that all products designed manufactured and distributed within ELAPAC scope meet all requirements and standards of quality and compliance. After the successful implementation of such a system, the position will be transitioning to an Operations role, driving service, efficiency and scalability.

The Quality Management System (QMS) would be in alignment with ISO 13485:2016 and other relevant regulatory requirements including, but not limited to FDA, EU MDR, APAC, LATAM, META local country regulations.

Key Responsibilities:

Quality Management System (QMS):

• Develop, implement, and maintain the Quality Management System in compliance with ISO 13485:2016 and other applicable standards and regulations. These include initiatives related to new product introductions and tests.
• Ensure all quality processes are documented and adhered to across the organization and entities.
• Conduct regular reviews and updates of the QMS to ensure its effectiveness and compliance.
• Conduct risk assessments and manage risk mitigation activities.
• Ensure that all suppliers and contract manufacturers comply with regulatory requirements and quality standards.
• Oversee the preparation and maintenance of comprehensive technical documentation for all products.
• Act as the key interface with regulatory and certification bodies

Compliance with Legal Manufacturer Obligations:

• Ensure compliance with all legal and regulatory obligations specific to the role of a legal manufacturer.
• Stay informed about changes in regulatory requirements and ensure the company’s compliance. (e.g. FDA, EU MDR, APAC, LATAM, META)

Operations Management:

• Lead day to day operations
• Drive service excellence
• Lead cross-functional coordination
• Manage capacity, resources and footprint evolution
• Maintain and continuously improve the QMS

Qualifications and Expertise:

Education:

• Bachelor's degree in engineering, Quality Management, or related field. Master’s degree preferred.

Experience:

• Minimum of 4 years of experience in quality management in the medical device industry.
• Proven experience with ISO 13485:2016 and other relevant quality standards and regulations.
• Proven track record in operations / supply chain

Skills:

• Leadership and change management capabilities.
• Excellent problem-solving and analytical skills.
• Pragmatic mindset: ensure business efficiency
• Chinese – Fluent, English – Fluent

Certifications:

• Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certifications will be an advantage.