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Quality Assurance Systems Specialist
2 months ago
We are seeking a dedicated and detail-oriented Quality Systems Engineer to join our team at Orion Electrotech, and ensure our products meet the highest standards of quality and safety.
Key Responsibilities:- Quality Management System (QMS): Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and FDA regulations.
- Regulatory Compliance: Ensure all processes adhere to applicable regulatory requirements, including FDA, ISO, and other relevant standards.
- Audits: Prepare for and participate in internal and external audits, including those conducted by regulatory bodies and customers.
- Document Control: Oversee document control processes, ensuring all quality-related documentation is accurate, up-to-date, and compliant with regulatory standards.
- Risk Management: Conduct risk assessments and develop risk management strategies to mitigate potential quality issues.
- Proven training and experience in auditing to the ISO13485 standard.
- Experience with QMS software and document control systems.
- Minimum of 2 years of experience in quality systems engineering.
