The primary role of Global Product Quality Assurance function is to design, implement and monitor quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.

 

Let's talk about Responsibilities

Register new equipment and manuals to the Database.

Organise timely outsourcing of calibrations and assess technical capabilities of Calibration Suppliers.

Resolve/raise technical calibration issues and provide general/technical support to customers and team in accordance with relevant standards, usage, service intervals, manufacturers’ specs.

Provide general administrative duties in Calibration Office.

Liaise with Finance, Purchasing for calibration orders, invoices and IT for office hardware/software.

Provide support in continuous improvement including supplier consolidation, cost reduction, process development.

Let’s talk about Qualifications and Experience

Recognises the contribution of quality systems and processes including good manufacturing practice (GMP) in delivering a consistent, traceable, superior quality product.

Prepares and maintains documentation and ensures equipment traceability.

Handles customer complaints and ensures an appropriate resolution is achieved for the customer.

Resolves quality and/or regulatory issues.

Supports the development of a continuous improvement culture in achieving superior products and competitive market positioning.

Demonstrates a sound understanding of QA/RA systems, operating parameters and interfaces.

Consults with the business to facilitate the generation of improvement ideas and innovations.

Attention to detail.

Basic knowledge and understanding of the Quality System Regulations, Quality Standards and various Standards.

Ability to establish good relationships with internal customers and calibration suppliers.

Self-starter, with the ability to work with minimal supervision and with a sense of urgency.

Good planning and organisational skills.

Please note you will be required to work onsite 5days/ week at 1 Elizabeth Macarthur Drive, Bella Vista, New South Wales, 2153, Australia. 

Required Experiences/ Skills

2 years minimum experience in an ISO certified industry (pharmaceutical, medical devices, or equivalent highly regulated industries).

Computer literate with proficiency in Microsoft Word and Excel.

Experience in calibration environment or good knowledge and experience of calibration, calibration management software.

Understanding of measurement uncertainties and calibration report reading in conjunction with calibration specifications.

Good knowledge and experience of Medical Device Quality System Regulations, calibration management and GMP.

WHS training.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!