Head of Quality ANZ

Job Title

Job Description

Philips is a leading global healthcare company aiming to improve the lives of 3 billion people by 2030. We strive to make the world healthier and more sustainable through innovation developed across a broad range of Imaging Information and Monitoring systems. With nearly 40000 employees working in 100 countries we are committed to helping create meaningful moments of care whether in the hospital room the living room or the boardroom.

Currently we are seeking an experienced Head of Quality ANZ to join the Philips Healthcare business.

Your Role

This is a critical position with overall responsibility for Quality Operation and Compliance Management for Philips across ANZ. Within this role you will have the opportunity lead a high performing team dedicated to ensuring only the highest quality standards are achieved. This role will report into the Head of Quality APAC and India and work as a key member of the ANZ Leadership Team.

Key Responsibilities Include:

To support the management and continuously improve all aspects of the Philips Quality Management and business information systems across Health System Sleep Respiratory Care and Personal Health and integrate global processes where appropriate. Be the business partner that will enable the delivery of Philips ANZ commitment to patient customers regulators and internal stakeholders.

• Managing the full implementation of the quality management system and ensure that the company is in compliance with standards and regulations (e.g. ISO13485 TGA Medical Device Regulations QSR MDR and other relevant quality standards and regulations Philips policies)

• Implementing most aspects of the quality system including document and data control management responsibility (including management review) quality planning training corrective and preventive action system internal & external quality audits etc

• Be the focal point of contact for the regulatory authorities in Australia & New Zealand.

• Interfacing directly with regulatory agencies in ANZ such as TGA Medsafe and other relevant Authorities

• Ensures proper internal and external audit preparation and execution for ANZ

• Deployment of global quality objectives with necessary local additions (or adjustments) to drive sustained improvements to QMS.

• Manage effective post Market surveillance process (such as feedback complaints correction Adverse event reporting) in ANZ Be part of district Leadership Team manage team budget and set-up strategic plans in alignment with function & business goals

• Works collaboratively with Customer Service and SCM organizations.

• Oversees personnel training for QMS processes.

• Lead district quality team through coaching developing and supervising for success.

• Partner with Regional & Local Business Process Owners to assist continuous improvement of processes and implement strategies for the continual development of the quality system based on worlds best practice and analysis of specific Philips ANZ needs

• Lead in the continuously maintaining an effective global policy framework to support Philips ANZ changing business needs

• Engage with both Quality Professionals and business partners to balance the needs of the business and regulatory requirements of a highly regulated industry. Supporting Q&R Capabilities such as Supplier Quality/ PQMS/ RA.

Youre the right fit if:

• A Bachelor or Masters Degree in Engineering Life Sciences Quality or Business Management

• Strong understanding and application of Industrial product regulations and standards.

• A strong practical knowledge of TGA regulation and other regulated markets such as US FDA EU MDR

• Ideally 10 years of related Quality Management experience in manufacturing/ commercial environment within Medical Device/ Pharmaceutical Industries.

• Experience in team leader / manager roles leading a team of professionals

• Certified ISO Auditor would be advantageous

How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.

If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips is an equal opportunity employer committed to building and supporting an inclusive workforce that reflects the diverse communities we operate within. Your application will be fairly assessed regardless of your race religion color national origin gender sexual orientation age marital status veteran or disability status.

Were living this commitment through our Reconciliation Action Plan and employee-led resource groups and we encourage people from all backgrounds including Aboriginal and Torres Strait Islander Mori and Pacific Peoples to apply.

Should you require assistance during your application process due to accessibility reasons we will accommodate this upon request.