Quality Assurance Manager
1 week ago
We are seeking a highly skilled Quality Assurance Manager to champion quality within our organization, ensuring that our corporate mission is fulfilled. As a key member of our team, you will be responsible for monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
Main Responsibilities:
- Championing quality throughout the organization.
- Maintaining and continuously improving our Quality Management System.
- Ensuring overall compliance to standard operating procedures.
- Developing audit programs and plans to ensure adherence to regulatory requirements.
- Performing internal audits and coordinating external audits to verify system effectiveness.
- Identifying opportunities for process improvements in company systems and processes.
- Managing CAPA related activities to prevent recurrence of nonconformities.
- Facilitating company and product development risk management to minimize potential risks.
- Overseeing quality control for medical device development to ensure conformity to regulatory requirements.
- Selecting and evaluating suppliers based on their quality management capabilities.
- Developing and conducting training sessions on QMS processes and policies to enhance employee understanding and adoption.
Requirements:
- A relevant qualification from a reputable education institution.
- No less than 5 years of experience in quality management or a similar role.
- In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
- Understanding of various production and manufacturing processes to ensure effective quality management.
- Excellent written and verbal communication skills in English.
- Able to work independently and collaboratively as part of a team.
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