
Chief Quality Officer
7 days ago
Job Overview
The Quality Assurance Specialist is responsible for championing quality within the organization, ensuring alignment with corporate mission and objectives.
Key Responsibilities:- Maintain and improve purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
- Ensure overall compliance to standard operating procedures in line with QMS.
- Develop and conduct internal audits, as well as coordinate external audits.
- Identify opportunities for improvement in company processes and systems, working with subject matter experts to drive implementation.
- Manage CAPA related activities and advise on relevant standards and regulations.
- Facilitate risk management, including product development, using best practices such as ISO 14971, IEC 60812, and ISO 31000.
- Manage quality for medical device development according to regulation (CE MDR, FDA, TGA) and standards (ISO 13485, IEC 60601, IEC 62304).
- Oversee calibration of test and measurement equipment and select suppliers.
- Develop and conduct induction training on QMS processes and policies.
Minimum Criteria:
- Relevant qualification from a reputable education organization.
- At least 5 years' experience in quality management or a similar role.
- In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements.
- Understanding of various production/manufacturing processes.
- Experience in communicating with and evaluating local and offshore suppliers.
- Excellent verbal and written English communication skills.
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