Employees at B. Braun are driven by one common vision to protect and improve the health of people around the world. Every minute, somewhere around the world, a B. Braun product or service is being used by a patient to recover from illness or a doctor to save someone's life. This knowledge breathes life into our work every day and motivates us to continually improve our solutions by working closely with medical practitioners and partners in constructive dialogue.
Job Description
Quality Management
- Responsible for post-marketing surveillance, including adverse event reporting, product complaints, and other ADR related activities.
- To ensure the organization operation is in compliance with corporate and local regulation for quality related requirement, especially GDP requirement.
- Initiate, review, revise and manage B. Braun Taiwan SOPs in full compliance with Taiwan regulations and company policies.
- Responsible for external/internal audits and audits to 4PL, dealers and vendors/suppliers (if necessary), also include to drive, monitor and follow up CAPA to ensure required actions completion on time.
- Responsible for the GDP evaluations / vendor assessments of 3rd party service providers for company outsourcing activities.
- Coordinate and promptly perform any recall / Field Safety Corrective Action (FSCA) operations.
- Ensure that a quality management system is implemented and maintained.
- Oversight B. Braun Taiwan whole company document management and document control in addition to document quality management related activities and maintain related records.
- Deliver Quality Management compliance related trainings to B. Braun colleagues and dealers/4PL vendor.
- Liaise with global quality management colleagues for quality management activities and projects.
- Provide regular quality management reports / project status and present the rationale and following action plan to the leadership team.
- Liaise with government officials or agencies for regulatory standards, close monitor all the related official notifications from government and information from industry associations, and then evaluate the impact on the B. Braun and prepare related procedures/documents accordingly including communicating changes with internal and external in a timely manner.
- Responsible for the company emergency contact for out of hours contact (e.g. emergencies and recall).
- The job description listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
Qualifications And Requirements
- University degree in business, marketing, medical science, medicine, nursing or related field
- Minimum 2 years of experience in Quality Assurance or Regulatory Affairs
- Relevant experience in medical device or pharma industry
Personal And Skills
- Ability to work cross functionally and in matrix organization
- Able to work independently and multi task
- Able to work as a team and possess good interpersonal skills
- Possess excellent spoken and written English as this role will deal with global teams
What We Offer
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.
