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Urgent! Director of Quality Job Opening In Singapore, Singapore – Now Hiring Thermo Fisher Scientific

Director of Quality



Job description

:

  • Develop and guide a Quality vision and strategic objectives aligned with the quality targets.
  • Lead and inspire the strong site quality organization by hiring and developing quality leaders, leading performance expectations, and providing development and training opportunities.
  • Use continuous improvement skills to boost product quality, cut costs, and align with objectives.
  • Establish site-wide QA priorities and key objectives to improve compliance with regulations and the Quality Management System (QMS).
  • Develop, implement, and ensure strict adherence to a quality system aligned with 21 CFR 820, ISO9001, ISO 13485, MDSAP, CE-IVDD, and CE-IVDR across all site locations.
  • Collaborate with corporate, group, and divisional quality partners on quality issues, audits, and special projects.
  • Further connections within LSG and regions, collaborating with essential collaborators to identify current deficiencies and future needs in Quality Management Systems for business expansion.
  • Develop the continual improvement of Quality Management Systems, being responsible for efficient management reviews, handling complaints, implementing CAPA system, regulating changes, conducting internal audits, and supporting the NPI process.
  • Support the commercialization of New Product Introductions by working with cross-functional NPI team members.
  • Collaborate with the Regulatory organization to ensure compliance with applicable regulations.
  • Serve as the Management Representative for Singapore to the US FDA and Notified Bodies
  • Perform other miscellaneous duties as assigned.
  • Minimum Requirements/Qualifications:

  • Bachelor’s degree in science or engineering fields or equivalent experience.
  • A minimum of 15 years of professional quality experience within the Life Sciences, Medical Device, Pharmaceutical, or IVD industry.
  • Customer focus: Prioritize customer needs in decision-making, work prioritization, resource investment, and process improvement.
  • Quality systems: Ability to implement strong quality systems (ISO 9001, ISO 13485, and MDSAP) that provide vital controls as defined by regulatory, marketplace, and customer requirements.
  • Regulatory experience: Preferred experience in IVD/IVDR, 510K, and GXP requirements.
  • Impactful Team Building: Ability to build a strong team, aligning strategy, interpersonal structure, and dedicated leaders.
  • Operational execution: Clear understanding of mechanisms vital to lead a quality assurance organization efficiently and reliably.
  • Flexibility and multitasking: Ability to lead multiple sophisticated projects simultaneously.

  • Required Skill Profession

    Operations Specialties Managers



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      Unlock Your Director of Potential: Insight & Career Growth Guide


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    • Interview Tips for Director of Quality Job Success
      Thermo Fisher Scientific interview tips for Director of Quality

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      Final Thought:

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