Senior Quality Team Lead

Position Summary

Principal Responsibilities

1.    Quality Audit Management:
•    Responsible in coordinating internal audit and external audit.
•    Ensure the internal audit plans and internal audit schedules are established and controlled accordingly. 
•    Ensure the audit file are maintained accordingly to the procedure.
•    Ensures the integrity of the company's Quality Management System in compliance to ISO 13485, MDSAP, MDD or EU MDR and other Regulatory requirements. 
•    Participate as an internal auditor during internal audit.
•    Act as NC initiator for all internal NC issued on internal audit findings.
•    Monitor nonconformance which initiated from internal and external audit and ensure timely reporting and closure. 
•    Coordinate in external quality system audits to ensure the fulfilment of the requirements of ISO 13485, MDSAP, MDD or EU MDR, and GDPMD, and other relevant regulatory requirements and international standards. 
•    Responsible in establishing internal auditor team and ensuring the competency of internal auditors.
•    Liaise with certificate bodies / notified bodies on new certification or recertification audit arrangement and documentation.
•    Coordinate and chair the pre-audit preparation weekly monitoring meeting before an announced external audit take place.
•    Ensure latest global procedure is effectively implemented on site. 

2.    Data Integrity Oversight
•    Ensure adherence to data integrity principles (ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate).
•     Monitor systems, processes, and documentation to ensure data integrity compliance.
•    Implement best practices for maintaining data accuracy, security, and traceability throughout the product lifecycle.
•    Lead training and awareness initiatives to promote data integrity across teams.
•    Conduct training programs for staff to ensure understanding and compliance with quality standards and data integrity practices.
•    Foster a culture of quality awareness, data security, and compliance across all organizational levels.

3.    Standard and Regulatory Monitoring 
•    Stay current with applicable regulations, guidelines, and industry trends regarding quality audits and data integrity.
•    Develop and enforce compliance standards and policies related to quality management and data integrity.
•    Collaborate with internal stakeholders (e.g., R&D, IT, manufacturing, and regulatory affairs) to ensure alignment with regulatory requirements and quality management systems.
•    Ensure that all deviations, non-conformances, and quality issues are thoroughly investigated and addressed.
•    Support the preparation and submission of responses to regulatory bodies and clients regarding audit findings
•    Maintaining standard and regulation watchlist. Monthly meeting cadence for Technical Review Board (TRB) Meeting for Standard & regulation monitoring
•    Managing the overall remediation activity of the watchlist for standards impact assessment for standards under Urology, AEM &Trachy ownership. Provided support in retaining the latest standard updates impacting Kamunting site and ensure gap assessment is in place for all standard revisions.
 

Education / Experience Requirements

Qualification    :    
Degree in Science or Engineering related field or Equivalent

Experience    :          
Experience and knowledge in Quality Management System requirements. 
Previous experience in industries such as pharmaceuticals, biotechnology, medical devices, or related fields is preferred.
Good understanding in regulatory requirements: ISO 13485/ EN ISO 13485, MDSAP, FDA 21 CFR Part 820, EU MDR/ MDD, MDA MDR and GDPMD.
Good understanding in cGMP and Data Integrity.
Qualified Lead/ Internal Auditor. Experience in coordination and execution of external and internal audit.         
Computer skills in Microsoft Office – Word, Excel and Power Point.

Specialized Skills / Other Requirements