Philips Head Quality ANZ 

Australia, New South Wales, Sydney 

421182129

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 world’s 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.

You're 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

We are a health technology company. We built our entire company around the belief that every human matters, and we won't 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.
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