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Job type: Permanent

Discipline: Good Distribution Practice (GDP)

Location: Australia

What if your expertise in quality engineering could help bring the next generation of life-saving cardiac medical devices to patients around the world

Proclinical is seeking a Biomedical QA Engineer to contribute to innovative cardiac biomedical engineering projects focused on diagnostic cardiac pacing and arrhythmia treatment. In this role, you will collaborate with a highly experienced team to implement and maintain medical-grade engineering processes, ensuring compliance with industry standards. This position also offers opportunities to expand your expertise in medical device regulatory affairs.

Responsibilities:

Implement and maintain engineering R&D processes in alignment with ISO13485 QMS and ISO62304 software standards.
Manage JIRA issues and oversee design reviews, design releases, and risk management activities.
Coordinate configuration management and technical file preparation for FDA submissions.
Support CAPA processes and participate in company audits.
Administer risk management procedures and ensure compliance with company SOPs.
Collaborate with cross-functional teams to achieve project goals.

Key Skills and Requirements:

Experience in quality assurance and regulatory affairs within biotechnology or a regulated industry.
Strong attention to detail and a commitment to accuracy.
Self-motivated with a proactive, can-do attitude.
Eagerness to learn and continuously improve on the job.

If you are having difficulty in applying or if you have any questions, please contact Pam Phoumavong at p.phoumavong@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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