Quality Assurance Manager
2 weeks ago
Job Summary: We are seeking an experienced Quality Assurance Manager to lead our company's efforts in obtaining dual ISO 13485 and ISO 9001 certifications.
As a Quality Assurance Manager at Virax Biolabs, you will be responsible for creating and managing all necessary documentation and processes, leading the submission process, and coordinating all activities required to achieve these certifications.
Key Responsibilities:
- Lead the development and implementation of the Quality Management System (QMS) for ISO 13485 and ISO 9001 certifications.
- Create and manage technical files, Standard Operating Procedures (SOPs), risk management reports, and other required documentation.
- Collaborate closely with product development and manufacturing teams to ensure alignment with quality standards.
- Serve as the main point of contact for external auditors and certification bodies.
- Perform internal audits and drive continuous process improvements.
- Train and educate internal teams on quality management processes.
Requirements:
- Minimum of 5 years of experience in the in-vitro diagnostics or medical devices industry.
- Proven experience in technical writing and documentation management.
- Prior experience working in a small company is highly beneficial.
- Ability to work independently in a fast-paced environment with excellent project management and problem-solving skills.
- Strong communication skills with the ability to collaborate across teams.
What Virax Biolabs Offers:
- Competitive salary package
- Performance-based bonus plans
- Employee stock options program
- 28 days of annual leave + Bank holidays
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