Quality Assurance Specialist
hace 1 semana
**Job Summary**
We are seeking a highly skilled Quality Assurance Specialist to join our team at Ws Audiology. As a key member of our Global Quality Team, you will be responsible for ensuring that customer complaints are captured, assessed, and resolved in a timely manner.
Main Responsibilities:
- Participate in Global Projects and improvements related to complaint handling processes.
- Be a key contact person for stakeholders and ensure that Global complaint process inspections and Audits (internal and external) are prepared and covered on local market.
- Perform follow-ups with investigators/LPoC/others to ensure complaints are processed in a timely manner.
- Continuously review complaint files to ensure documentation is performed according to requirements (internal/external) and in line with GDP needs.
- Perform initial screening of new complaints to determine potential reportability, investigator, and appropriate investigation location.
Requirements:
- Working experience in complaint handling and customer quality required.
- Knowledge of Operational processes.
- Experience in complaint handling processes for medical devices.
- Knowledge of FDA regulations, ISO13485.
- Ability to actively participate and present during External/internal Audits, FDA Inspections.
What We Offer:
- Permanent contract.
- Full-time position.
- Competitive salary and benefits package.
Language Requirements:
- English: Spoken: 90%, Written: 90%.
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