
Senior Quality Assurance Specialist
3 days ago
The Quality Assurance Manager will spearhead quality efforts within the organisation, ensuring overall compliance to standard operating procedures in line with the Quality Management System.
Key responsibilities include monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
Responsibilities- Driving quality initiatives across the organisation, towards fulfilling corporate objectives.
- Overseeing, refining and enhancing our bespoke Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
- Ensuring overall adherence to standard operating procedures in line with the Quality Management System.
- Developing audit programmes and plans, conducting internal audits and coordinating external audits.
- Identifying, planning and documenting opportunities for improvement in company processes and systems and collaborating with subject matter experts to drive implementation.
- Managing and processing Corrective Action Preventative Action related activities.
- Identifying and advising on relevant standards and regulation for product developments, maintaining up-to-date libraries of applicable standards and regulations across global markets.
- Facilitating organisational and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
- Facilitating appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.
- Managing quality for the development of medical devices according to regulation such as CE MDR, FDA and TGA and standards including ISO 13485, IEC 60601 and IEC 62304.
- 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 induction and training on Quality Management System processes and policies, and promoting Quality Management System regulatory requirements to all staff.
- A relevant qualification from a reputable educational institution.
- At least five years' 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/manufacturing processes.
- Experience in communicating with and evaluating local and offshore suppliers.
- Excellent verbal and written English communication skills.
- Ability to work independently and as part of a team.
- ISO 17955 Lead Auditor certified.
- Quality management experience in product design and development.
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