Senior Quality Excellence Manager

5 days ago

Singapore beBeeExcellence Full time $96,000 - $144,000

Job Title: Quality Excellence Manager

Job Description

We are seeking a highly skilled Quality Excellence Manager to lead our quality management system and drive a culture of compliance, responsiveness, and data-driven decision making. This role will ensure that the quality team is structured appropriately and provides direction to individuals reporting to them.

  • Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards and regulations.
  • Manage internal and external quality audits to ensure compliance with standards and regulations.
  • Report on the performance of QMS to executive management regularly.
  • Ensure effective management of the site's Quality System, including CAPA, Deviations, Nonconformance, Document Control, Supplier Quality Management, Complaints, Audits, etc.
  • Promote awareness of regulatory and customer requirements throughout the organization and ensure employee compliance with those requirements.
Required Skills and Qualifications
  • Minimum 10 years of progressive responsibilities in quality assurance and control in manufacturing or equivalent.
  • Robust knowledge of ISO 13485, FDA 21 CFR Part 820, and/or the Medical Device Directives for medical business and ISO 16949 for automotive business.
  • Strong understanding of injection molding process and tooling.
  • Computer literate in Microsoft Office applications.
  • Demonstrated proficiency utilizing engineering tools (i.e. FMEA, MSA, DOE, SPC, statistical tools, etc.).
About this Job

This is an exciting opportunity to join our team as a Quality Excellence Manager. If you have a passion for quality management and a desire to make a difference in a dynamic organization, we encourage you to apply.

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