
Compliance Expert
5 days ago
The Compliance Expert plays a critical role in maintaining an efficient and effective Quality Management System (QMS) in accordance with international standards such as ISO 13485, CE, BIS, QSR, and other applicable global regulations for medical devices.
Key Responsibilities:- Evaluate the effectiveness of internal controls, processes, and systems to ensure compliance with regulatory and company requirements.
- Develop and maintain an audit schedule based on risk assessment and regulatory requirements.
- Plan, prepare, and conduct audits of manufacturing, assembly, quality, and support processes.
- Conduct process, product, and system audits in various departments, including production, engineering, store, warehouse, calibration, and validation.
The successful candidate will have experience with:
- ISO 13485 and regulatory requirements.
- Process improvement principles for audits.
- Quality Management System documentation and technical file management.
- Root cause analysis, complaint handling, and corrective action implementation.
This is an exciting opportunity to join our organization and contribute to the development and maintenance of our Quality Management System. As a Compliance Expert, you will play a key role in ensuring that our operations are compliant with relevant laws and regulations.
RequirementsTo be successful in this role, you will need:
- Experience working with ISO 13485 and regulatory requirements.
- Strong knowledge of process improvement principles and their application in auditing.
- Ability to develop and maintain an audit schedule based on risk assessment and regulatory requirements.
- Excellent communication and interpersonal skills.
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