Senior Quality Assurance Specialist
We are seeking a detail-oriented and proactive individual to join our team as a Senior Quality Assurance Specialist.
Job Description
The successful candidate will be responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, including ISO 13485:2016 and the fully implemented EU MDR. This role is critical in maintaining product integrity through rigorous risk assessments, validation protocols, and effective change control processes.
Main Responsibilities:
* Product Validation: Develop and execute comprehensive validation protocols (IQ/OQ/PQ) to ensure high-degree assurance of product requirements.
* Risk Management: Lead and maintain risk management files, identifying potential failure modes through p FMEAs.
* Quality Support: Provide real-time QA support to operations teams addressing non-conformances, performing root cause analysis, and implementing CAPAs."
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