And another job on Seek

Quality Assurance Manager

Private Advertiser

Resonance Health is looking for an experienced part-time (approx 0.6-0.8 FTE) Quality Assurance Manager.

Resonance Health is a progressive company focusing on the development and delivery of specialised testing services and tools to the diagnostic imaging market. Our services are used by health care professionals and pharmaceutical companies across the globe. The Company is certified to ISO 13485:2016 and has TGA, CE Mark, FDA and Medsafe medical device clearance.

We provide a number of products and services to global medical and pharmaceutical communities, including our flagship product, FerriScan®, which is globally recognised as the gold standard for measurement of liver iron concentration (LIC). We also develop new diagnostic imaging methods and products to improve patient outcomes in line with our diversification strategy to add value to our product portfolio.

The successful candidate will have a passion for quality, a drive for continuous improvement and high attention to detail, whilst continually seeking ways to maximise efficiency in the organisation. You will oversee the Quality Management System, QA activities, audits and customer feedback. Reporting directly to the CEO, this is a key role within the organisation, working closely with the Operations and R&D departments. You will have one Compliance Officer reporting to you.

About the role:

Your key responsibilities will include:

• Maintain full compliance with certified ISO standards and Australian, European, US, Canadian, and New Zealand Medical Device Regulations.
• Maintain the currency and effectiveness of the quality management system through a process of continual improvement.
• Manage non-conformances and customer complaints in the production environment.
• Review and sign-off of quality documentation including product release.
• Act as the Management Representative for the company.
• Act as the Privacy Officer

About you:

The successful candidate will ideally possess the following attributes:

• Excellent verbal and written communication skills and attention to detail.
• 3 to 5 years Quality Assurance experience, preferably in medical devices, pharmaceuticals or life science industry (required)
• Familiarity with managing a Quality Management System (required)
• The ability to work within a small team, highly adaptable, good negotiation skills while ensuring compliance with the QMS.
• Knowledge of the regulatory requirements for medical devices within Australia, Europe, US, Canada, and New Zealand, including ISO 13485 and ISO 14971 (desirable)
• Knowledge in software development (desirable)
• Knowledge in Privacy and Data protection, including Australian Privacy laws, GDPR and HIPAA/HITECH (desirable)
• Tertiary qualifications in a related science, biotechnology or similar field.

Remuneration, work hours and term of contract will be negotiated with the successful candidate.