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Sr. Quality Assurance Specialist - Now Hiring!

Sr. Quality Assurance Specialist - Now Hiring!

Zimmer BiometTaichung, Taichung, Taiwan
30+ days ago
Job description

Valued Team member : We are glad you are exploring new opportunities within Zimmer Biomet!

What You Can Expect

Responsible for managing all facets of quality assurance support and quality system processes for Zimmer Biomet Taiwan. This includes ensuring compliance with the corporate requirements, TFDA regulations, ISO 13485 Quality System Standard and other applicable regulations. Able to lead quality improvement projects and resolves problems that have implications beyond own area of responsibility. Require professional expertise and interpersonal skills to manage multiple projects.

How You'll Create Impact

Responsibilities

  • Manage all complaint handling, AE, quality field actions, recalls and PMS data collection or reporting in Taiwan. Report to health authorities, APAC or Corporate QA as requested. Prepare monthly updates to Taiwan RAQA Manger and APAC QA.
  • Maintain quality files and database to meet / support company and government requirements e.g. transplantation record & feedback form.
  • Oversee the Zimmer Biomet Taiwan GTS database and ensure the process implementation, operations are fully compliance with Taiwan local regulations.
  • Leads (or co-leads) and participates the external audit by government health agencies, Notified Bodies, authorized third parties and corporate . Manage and support the establishment and maintenance of Zimmer Biomet Taiwan quality system, GDP, QMS procedures, work instructions and records.
  • Execute internal audits and monitor quality related operations for continuous quality improvement in Zimmer Biomet Taiwan.
  • Responsible for CAPA to ensure complete closures and effectiveness.
  • Direct quality improvement projects in Taiwan to ensure alignment with international standards, corporate requirements, local regulations and provides regular communication to Corporate and APAC QA.
  • Be knowledgeable of the latest regulatory and corporate requirements concerning quality and quality systems. Update the necessary processes and procedures in Taiwan accordingly, providing regular updates to APAC QA as required.
  • Develop effective strategies to cope with issues related to quality assurance.
  • Ensure the organization operation is in compliance with corporate and local regulation for quality related.
  • Develop and maintain good working relationships with functional areas that support product and quality in Zimmer Biomet Taiwan.
  • Support the projects assigned by Taiwan RQA manager.

Your Background

  • Minimum Bachelors' degree (life sciences or equivalent field is preferred).
  • Minimum 3-5 years QA work experiences in multinational medical device or pharmaceutical companies
  • Good command of the English and Chinese languages (speaking, reading and writing)
  • Knowledge of ISO 13485, QMS and GDP.
  • Strong attention to detail, ability to multi-task
  • Superior interpersonal and communication skills
  • Proactive in taking initiative and prioritizing pipeline projects
  • Good computer skills (Microsoft Office, Winchill, etc)
  • Responsible, professional, detail oriented and with patience

    • EOE / M / F / Vet / Disability

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    Sr Quality Assurance • Taichung, Taichung, Taiwan