Quality Assurance Specialist
1 day ago
A Quality Assurance Specialist is responsible for championing quality within the organization.
About The Role:
- Monitoring and maintaining our purpose-built quality management system in accordance with ISO standards.
- Ensuring overall compliance to standard operating procedures.
- Developing audit programs and plans, performing internal audits and coordinating external audits.
- Identifying opportunities for improvement in company processes and systems and driving implementation.
- Managing CAPA related activities.
- Advising on relevant standards and regulations for product developments.
- Facilitating risk management in accordance with best practices.
- Managing quality for the development of medical devices according to regulation and standards.
- Managing the calibration of test and measurement equipment.
- Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
- Developing and conducting training on quality processes and policies.
Requirements:
- A 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 production/manufacturing processes.
- Experience in communicating with and evaluating suppliers.
- Excellent verbal and written English communication skills.
- Ability to work independently and as part of a team.
Preferred Skill And Experience:
- ISO Lead Auditor certified.
- Quality management experience in product design and development.
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