Software/QA Specialist

Job ID: 1234 | Planet Innovation Pty Ltd

• Award-winning organisation at the forefront of innovation
• Fantastic company culture
• Be recognised and rewarded for your contribution

As part of our continuous growth we are looking for an accomplished and highly experienced Software/QA Specialist to work closely with the QA/RA Manager and his high-achieving team of skilled professionals.

The company offers a fantastic and mature work culture where honest and open feedback is encouraged; there are real opportunities for progression and each team member directly influences their central vision of creating breakthrough products and commercially successful businesses that transform industries and have a positive impact on the world.

The Role:

Software related activities including validation and process surveillance

• Software evaluation (for QA purposes).
• Plan execute and report software validation exercises.
• Analysis of validation and revalidation criteria.
• Maintenance of software validation register.
• Author process documentation regarding software development.
• Examination of software development processes for conformance to IEC62304.
• Development of training for compliance to IEC62304.

QMS Related development and maintenance

• Author or coordinate changes to Quality Documents including procedures and templates.
• Maintain Quality Issue Management System.
• Create entries for issues raised in audit reports.
• Review/follow up issues as assigned.
• Perform internal audits as assigned.
• Address quality issues as assigned.
• Assist in setting, monitoring and achieving company quality objectives.
• Assist the QA/RA Manager in reporting to top management on the performance of the Quality management system and any need for improvement.
• Assist the QA/RA Manager in liaising with external agencies that relate to the Quality System.

Risk and Hazard Management Process Surveillance

• Author process documentation regarding product and project risk management.
• Examination of risk management processes for conformance to ISO14971.
• Development of training for compliance to ISO14971.

To be successful:

You need to have solid experience in a similar role with specific experience in the Medical Devices field (IEC62304).

With each project comes new challenges, so we need people who can tackle them head on using their range of experiences, possess excellent and effective communication and organisation skills and be a self-starter and strong team player. Ideally you will be an ambitious individual who is looking to grow a long-term career with us.

The Company

Planet Innovation is a HealthTech Innovation and Commercialisation company.

We have our own portfolio of businesses, and also partner with world-leading organisations to help them create game-changing innovations to grow their business. To achieve this, we have hand-selected over 250 of the brightest people, gathered deep market insights and developed a full spectrum of commercialisation capability to help us build the future.

Planet Innovation is an equal opportunity employer. We champion diversity and are committed to creating an inclusive environment for all employees.