• Responsible for leading the Quality Management Systems (QMS) team in the area of Training, Supplier Quality Management, Documentation Control and Change Management.
• Facilitating the Management Review
• Oversight of CAPA process and Quality Audits (both internal and external).
• Partner with the relevant team leads of quality departments/functions at the respective system houses to stay aligned in Change management and contribute in Quality System harmonization/alignment efforts.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
• Provides oversight and lead the QMS team in the area of Training, Supplier Quality Management, Documentation Control and Change Management, CAPA, and Quality Audit.
• Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
• Serve as primary or alternate liaison to FDA and/or Notified Body/Certification Body officials during audits of the site.
• Lead site specific audit readiness activities.
• Direct and/or conduct investigations into potential quality/compliance concerns. Keep management informed of issues.
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
• Lead special quality improvement projects / BU QMS initiatives, including systems definition, validation, training and rollout.
• Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements.
• Technical / scientific degree at college / university level (mechanical, biomedical, polymer engineer-ing, natural sciences).
• At least five years' work experience in a quality function in regulated environment
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, MDD, AIMD, applicable local regulations.
• ISO 13485 auditor Certification.
• Experience as lead/auditee in third party audits (FDA, Notified Bodies, Competent Authorities).
• Supplier Quality Management Experience would be a value add.
• Technical knowledge and experienc
• Responsible for leading the Quality Management Systems (QMS) team in the area of Training, Supplier Quality Management, Documentation Control and Change Management.
• Facilitating the Management Review
• Oversight of CAPA process and Quality Audits (both internal and external).
• Partner with the relevant team leads of quality departments/functions at the respective system houses to stay aligned in Change management and contribute in Quality System harmonization/alignment efforts.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
• Provides oversight and lead the QMS team in the area of Training, Supplier Quality Management, Documentation Control and Change Management, CAPA, and Quality Audit.
• Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
• Serve as primary or alternate liaison to FDA and/or Notified Body/Certification Body officials during audits of the site.
• Lead site specific audit readiness activities.
• Direct and/or conduct investigations into potential quality/compliance concerns. Keep management informed of issues.
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
• Lead special quality improvement projects / BU QMS initiatives, including systems definition, validation, training and rollout.
• Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements.
• Technical / scientific degree at college / university level (mechanical, biomedical, polymer engineer-ing, natural sciences).
• At least five years' work experience in a quality function in regulated environment
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, MDD, AIMD, applicable local regulations.
• ISO 13485 auditor Certification.
• Experience as lead/auditee in third party audits (FDA, Notified Bodies, Competent Authorities).
• Supplier Quality Management Experience would be a value add.
• Technical knowledge and experience to work effectively with others in diverse areas of business (Operations, R&D, Facility Management, HR, Procurement, Finance)

Veronica Neo Shen Hwa - veronica.neo@manpower.com.sg
Personnel Reg No: R1110855
Manpower Staffing Services (S) Pte Ltd
EA Licence No: 02C3423

Veronica, Shen Hwa Neo EA License No.: 02C3423 Personnel Registration No.: R1110855

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