Quality Systems Specialist, Medical Devices

  • Location

    Singapore

  • Sector:

    Engineering & Manufacturing

  • Job type:

    Permanent

  • Salary:

    S$4500 - S$6000 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH9572_1627016456

  • Published:

    almost 3 years ago

  • Expiry date:

    2021-08-22

  • Consultant:

    ConsultantDrop

My client is a world leader in the medica device industry and is going through a transformation project. To cater to this, a new Quality Systems Specialist role has been created

  • Global Name
  • World Leader
  • High Salary

Responsibilities:

  • Ensure the process and product change control process complies with Quality Systems Regulations
  • Provide oversight for development and maintenance of engineering change control processes and procedures to ensure compliance with policies
  • Lead and support product and governance on the lifecycle and manufacturing of products
  • Evaluate and perform assessment on the Process and Product Change Requests
  • Lead and provide support in the establishment of appropriate master data settings to facilitate product ramp-up
  • Collaborate with regional and global teams to ensure that product lifecycle strategies are implemented properly in the SAP system
  • Work closely with Quality, Engineering, and Supply Chain to gather relevant information on Materials/ BOM and Routings for new products
  • Lead and oversee the configuration activities related to product or process changes
  • Support the collaboration of Master Data Governance and play a Change Coordinator role as a Quality representative to coordinate the change communications
  • Lead and execute change control processes and systems for improvement.

Requirements:

  • Degree in Science, Engineering or equivalent with at least 2 - 5 years' experience
  • Experience in managing change control and product changes
  • Expertise with regulatory documentation and procedures
  • Prior knowledge in software validation, UAT and documentation of test cases
  • Basic know-how of manufacturing processes/Bill of Materials/Material requirements
  • Knowledge of ISO13485, CFDA and FDA requirements
  • Excellent communication and negotiation skills

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).

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