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Senior Quality Assurance Manager

Programmed

Job Description

The Company

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.

The Role

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

Applications

If you meet the criteria and are interested in this opportunity, please apply online in the first instance. Alternatively, contact Keelie Munroe via email keelie.munroe@persolkelly.com.au or 0400 240 737 for a confidential discussion.