QA Executive

QA Executive

Medulla Pro Technology Pte. Ltd.
2-5 years
42000 - 54000 SGD

Job Description

Job Description

  • Participate in new product development projects and support design control, risk management activities
  • Develop experimental designs, evaluate feasibility/characterization studies, and validation of equipment, test protocols/ methods, software, and manufacturing processes
  • Prepare the process and support the evaluation of supplier management, which includes but not limited to supplier evaluation, audits and qualification
  • Prepare and document Quality Management System (QMS) requirements between Contract Manufacturers and the Portfolio Companies
  • Draft, review and implement companies’ Quality Management System
  • Assist in the document control for the companies
  • Support in the review of companies’ design history file
  • Support and facilitate ISO 13485 certification related activities

Requirements/Skills

  • Certified Quality Engineer
  • Min. Bachelor Degree in a relevant science/ engineering discipline
  • 2-4 years of QA experience in medical device design and development processes, such as developing design verification and validation protocols and reports, and design transfer procedures
  • Design and Development/ Supplier Management/ QMS implementation/ or Document Control experience preferred
  • Experience in facilitating quality standards in relation to manufacturing processes and has experience in validating these processes to support the companies’ manufacturing needs
  • Good knowledge of quality systems and QA principles, practices and standards
  • Ability to interpret and relate Quality Standards for implementation
  • Proven ability to work well under pressure

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