The Senior Quality Assurance Associate plays a critical role in ensuring the Quality Management System (QMS) is robust, effective, and compliant with applicable global regulatory requirements and internal procedures. As a senior team member, you will provide expert-level support and leadership across QA systems, drive continuous improvement initiatives, and collaborate cross-functionally to ensure quality standards are upheld throughout the organization. This position will involve mentoring junior staff, leading audits, and contributing strategically to QA planning and execution.

Key Duties:

Lead and conduct regular internal audits and external gap analyses to ensure compliance with ISO 13485, TGA, and IVDR requirements.

Own and manage the document control system, ensuring timely updates, approvals, and adherence to SOPs and regulatory standards.

Analyze and interpret complex scientific data to support quality initiatives and regulatory submissions.

Deliver QMS and regulatory compliance training across departments to strengthen organizational quality awareness.

Champion the achievement of corporate quality goals and continuous improvement initiatives.

Serve as a key liaison between QA and other departments, building collaborative and productive relationships across functions.

Oversee product compliance processes, including non-conformance investigations, CAPA, and trend analysis.

Manage end-to-end processes for product complaints, adverse event reporting, and vigilance reporting.

Collaborate with R&D and cross-functional teams to ensure smooth and compliant product transition from development to commercialization.

Lead the customer advisory notification process, ensuring timely and accurate communications.

Coordinate and support audit readiness and lead preparations for external audits and inspections.

Required Skills & Qualifications

Bachelor’s degree in science, Biotechnology, Software Engineering, or a related discipline.

Minimum 3 years' experience in a Quality Assurance role within the Medical Device or In Vitro Diagnostics (IVD) industry.

Proven experience supporting QA systems in IVD manufacturing environments.

Deep understanding of ISO 13485 quality standards and their application in QMS.

Hands-on experience with TGA Conformity Assessment and IVDR compliance.

Strong organizational, analytical, and problem-solving skills.

Excellent written and verbal communication, with the ability to influence and guide stakeholders.

Demonstrated ability to lead audits and manage multiple projects independently.