A global company that are at the forefront of genomics and bioinformatics technology to improve non-invasive diagnostics. The company is a world leader in genetic sequencing and are responsible for the development and manufacture of medical devices locally based in Perth. An enticing opportunity exists for a Senior Quality Assurance Manager to lead the quality team on compliance with regulations for the development and manufacture of medical devices.
A permanent, full-time position is available for an experienced Quality Assurance Manager to oversee both the local and global QA/RA team. Reporting to the Senior Vice President Operations, this position will be focused on ensuring compliance in accordance with ISO regulations, TGA, IVD, EU & Canada for medical devices. The following responsibilities can be expected:
Internal & external auditing
Lead product development activities from a QA/RA perspective
Submissions for regulatory approval and product registrations
Overseeing the QMS for compliance to regulatory standards for medical devices
Review data on products before final release
Provide training to company personnel in relation to quality matters and areas of improvement
Liaise with regulatory bodies
Manage the approved suppliers list, including the review of the performance or suitability of suppliers
Manage and implement CAPAs
Skills and Experience
BSc or higher in Medical Science or equivalent.
Demonstrated experience in internal and external auditing
Relevant medical testing laboratory, R&D, or medical device experience
Experience in ISO13485 highly regarded
Familiar with regulations: ISO, TGA, EU, IVD, Canada.
Full working rights in Australia
If you meet the criteria and are interested in this opportunity, please apply online in the first instance. Alternatively, contact Keelie Munroe via email email@example.com or 0400 240 737 for a confidential discussion.