Manager – Quality & Post Market
Make an impact in our Quality space.
The main objective of this role is to ensure Stryker South Pacific (SSP) complies with all requirements of the SSP Quality Management System as defined by Stryker Corporate, ISO 13485 Standard and Australia and New Zealand regulations, specifically in relation to Post Market activities.
This role involves coordinating key activities in line with strategic objectives with key stakeholders across the business both local in SSP and Global, particularly Marketing, Sales, Regulatory, Service and Operations and leading the Post market team to ensure objectives are met.
All aspects of the role must follow Quality system requirements, company policies, regulatory requirements, ISO 13485 and be in alignment with strategic imperatives, in addition to meeting internal and external customer demands.
What You Will Do
Oversee the QMS System and serve as the delegate for Management Representative as required by ISO 13485.
Maintain and continuously improve the ISO 13485-certified QMS to meet TGA, regulations and corporate requirements.
Manage and lead regulatory body communication, ensuring key regulatory reporting timelines and requirements are met consistently act as a key point of contact for post market escalations internally and externally.
Ensure processes and procedures are documented appropriately per requirements and are continually assessed.
Drive a culture of Quality across the entire organisation, working closely with cross-functional teams to ensure quality objectives are met across the company.
What You Will Need/Required Qualification
Minimum 2 years of experience in quality or regulatory affairs.
Experience preparing for audit, maintaining and outlining quality standards
Professional knowledge gained through substantial work experience in healthcare quality assurance.
Exceptional attention to detail and the ability to make evaluative judgments based on factual information.
Proficiency in quality management systems and tools.
Strong communication and leadership skills.
Work Location: Hybrid remote in Sydney NSW
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