Quality Assurance Specialist

7 days ago


Shanghai, Shanghai, China Abbott Full time

About the Role:

As a Quality Assurance Specialist at Abbott, you will play a critical role in ensuring the quality of our products and services. Your primary responsibility will be to identify and interpret internal requirements and external laws, regulations, guidance, and standards (LRGS) applicable to our quality systems.

Key Responsibilities:

  • Ensure internal activities and external partnership activities meet applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485.
  • Interpret applicable internal requirements and external LRGS and incorporate them into requirements for use in business processes internally or with external partners.
  • Maintain and communicate monthly metrics to stakeholders.
  • Review and approve product design changes and Quality System documentation.
  • Maintain external partner files and create Quality System and/or external partnership-related documents.
  • Review external partnership assessment forms and assist in the execution of onboarding and maintenance activities.
  • Participate in external inspection/audit activities.
  • Perform other duties as assigned by Management.

Requirements:

  • Bachelor's Degree (± 16 years) in Life Sciences, Physical Sciences, Engineering discipline, or equivalent technical degree, or an equivalent combination of education and work experience.
  • Strong communication skills.
  • Quality Assurance experience.
  • Medical Device manufacturing or pharmaceutical industries.
  • Working knowledge of applicable regulations and standards, such as FDA QSR and ISO 13485.


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