Address The Senior QA/RA engineer will ensure that all external and internal quality and appropriate
regulatory requirements have been met and all selected suppliers are audited and met the
Regulatory and company requirements.
They will be responsible for providing the procedures (SOPs), documenting, inspecting, and
testing procedures and outputs to meet the respective requirements and identify non-
conformity issues. With a senior experience in auditing and regulatory affairs the QA/RA
engineer will be a reliable and competent professional whose approval will be necessary for
the continuation of a quality process and supplier evaluation. The goal is to assure high
quality of operations and services, and flawless regulatory compliance in Australia aiming for
the long-term success of our business.
Duties and activities that constitute the performance of the job
? Implementation of ISO 13485 requirements
? Providing regulatory pathway for registration of new medical device as per TGA/ EU
MDR requirements.
? Create, review, update, and enforce quality and operational procedures in alignment
with company quality policy and applicable regulatory requirements.
? Supplier audit, supplier assessment, supplier evaluation and re-evaluations.
? Undertakes tasks related to the company’s QMS (e.g. document control, supplier
control, inventory control, NCR/CAPA, customer feedback, and post-market
surveillance)
? Internal quality management system audit (according to ISO 13485/ EU MDR/ TGA
requirements)
? Handling and managing all external audits by Certification Bodies & Notified Bodies
for obtaining the relevant certificates.
? Conduct Personnel Training Review
? Maintain Equipment Calibration and Maintenance and Standards/Certifications
? Maintain company compliance to Standards/Certifications
? Assist in Management review of QMS.
? Ensure effective record keeping across QMS.
Required Qualifications and Experience
? Minimum 5 years in medical device industry
? Minimum 2 years regulatory auditing experience (3 rd party auditor is preferable)
? At least BSc degree relevant to medical devices (e.g. Biomedical engineering,
Bioelectric engineering, Biomaterial engineering, etc)
Desirable Skills
? Professional experience in Regulatory and Quality requirements
? Professional experience in a medical device company
? Experience developing and overseeing a QMS.
? Experience in auditing of medical device manufacturers.
? Experience conducting supplier assessment and audits.
? Experience fronting external auditors (Notified Bodies), including regulatory
compliance.
? In-depth knowledge of EU MDR, TGA, ISO 13485 and ISO 14971 requirements.
? An organised mindset with outstanding organisational and leadership skills
? Analytical abilities and problem-solving skills
? Excellent communication and presentation skills
? Understanding of different business disciplines (IT, finance, research, product etc.)
? Proficient in Microsoft 365
