
Quality and Regulatory Associate
2 weeks ago
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.
- Engineering degree (biomedical or electronics engineering preferred)
- 2–3 years experience in quality and/or regulatory management
- Experience in composing and maintaining operation procedures and work instructions
- Experience in performing internal/external audits (preferred)
- Good knowledge of medical device regulations (preferred)
- Very good working knowledge of MS Office
- Excellent command of English
Responsibilities and Duties
This role involves:
- Ensuring compliance with regulatory and statutory requirements
- Staying informed of any changes in relevant regulations and ensuring Fisher & Paykel Healthcare Turkey compliance
- Managing and monitoring internal QMS requirements
- Collecting data and producing statistical reports on Quality related metrics
- Performing internal audits according to QMS procedure
- Identifying, documenting, and taking preventative and corrective actions in relation to issues of non-conformance
- Assisting in running Management Review Meetings and Quality Meetings in accordance with procedure and ensuring metrics within Quality Plan are reviewed and measured
- Promoting the quality culture across the business
- Ensuring after sales technical service
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