QUALITY ASSURANCE MANAGER | MEDICAL DEVICES

Summary about this job

Detail information about job QUALITY ASSURANCE MANAGER | MEDICAL DEVICES. Terms and conditions vacancy

• UPTO $110k BASE FIGURE + SUPER + PRIVATE HEALTH + BONUS
• PRIME SOUTHEAST LOCATION | WORLD LEADING PRODUCTS
• GLOBAL BRAND - GREAT WORK LIFE BALANCE

We are looking for a Quality Manager covering Oceania from Melbourne to work within the Medical Devices Industry. Reporting to the Global VP for Quality Assurance this is a senior role with direct reports in different regions.
As Quality Manager your key responsibilities will include:

• Setting strategy to enhance and maintain regional Quality Assurance Programs, (in relation to processes managed, products produced, markets served)
• Assigning Quality System Management Representative; primary regulatory agency and customer contact on all quality related queries for the region e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.
• Selecting & providing guidance, direction and supervision to Quality Assurance Personnel – approx. 4 reporting to this person
• Develop and manage quality departmental budgets.
• Key member of Regional Senior Leadership Team that manages, develops and drives to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.
• Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
• Partner with Research and Development (Product & Technology)

In order to apply for this role you will need the relevant tertiary qualification & substantial experience in a similar role within the Medical Devices Industry. You will have a proven track record in leading organisations through external inspections / audits (e.g. TGA, Notified Bodies, Competent Authorities, Customers), as well as working knowledge of and experience with TGA regulations, ISO 13485 Quality System Standard, and ISO 14971 Risk Management. You will have strong leadership ability & be able to influence people at all levels within the organization. A part of the role is reviewing data, analysis, trends, reporting, so you will need a passion for this along with the ability to read and interpret documents.  In addition to this you will have the ability to write clearly and informatively technical documentation, routine reports & be able to demonstrate strong project management skills.