Quality and Regulatory Associate

2 weeks ago


Çankaya, Ankara, Turkey Fisher & Paykel Healthcare Full time

About the job

Fisher & Paykel Healthcare is a major employer in the medical device industry, with a global reach. Our company operates in 40 countries and distributes products to over 125 countries worldwide. We are a well-established and innovative company with a history of strong and continuous growth.

The Role

Developing and managing Fisher & Paykel Healthcare's Regulatory and Quality Management System is crucial for delivering customer-centric quality management that adheres to all applicable regulations and meets business objectives. This role will also involve covering after-sales technical service.

Qualifications

To be successful in this position, candidates should possess excellent interpersonal skills, problem-solving skills, planning and project management skills, an analytical mindset, and be detail-oriented, self-motivated, and proactive.

  1. Engineering degree (biomedical or electronics engineering preferred)
  2. 2–3 years experience in quality and/or regulatory management
  3. Experience in composing and maintaining operation procedures and work instructions
  4. Experience in performing internal/external audits (preferred)
  5. Good knowledge of medical device regulations (preferred)
  6. Very good working knowledge of MS Office
  7. Excellent command of English

Responsibilities and Duties

This role involves:

  1. Ensuring compliance with regulatory and statutory requirements
  2. Staying informed of any changes in relevant regulations and ensuring Fisher & Paykel Healthcare Turkey compliance
  3. Managing and monitoring internal QMS requirements
  4. Collecting data and producing statistical reports on Quality related metrics
  5. Performing internal audits according to QMS procedure
  6. Identifying, documenting, and taking preventative and corrective actions in relation to issues of non-conformance
  7. Assisting in running Management Review Meetings and Quality Meetings in accordance with procedure and ensuring metrics within Quality Plan are reviewed and measured
  8. Promoting the quality culture across the business
  9. Ensuring after sales technical service


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