Hybrid

As a Quality Assurance Associate, you’ll play a pivotal role in ensuring our operations meet the highest standards of compliance and quality. You’ll manage key quality management processes in alignment with international standards, Stryker Corporate policies, and regulatory requirements in Australia and New Zealand. This role is highly collaborative, partnering across departments—Sales, Marketing, Regulatory, Service, and Operations—to drive a quality-first mindset and ensure patient safety and regulatory excellence.

You’re a detail-oriented problem-solver with outstanding attention to detail, curiosity and a strong ability to develop meaningful relationships quickly. You thrive in complex, layered environments, enjoy collaborative work, and have a knack for translating complex concepts into practical business processes. You’re proactive, analytical, and committed to continuous improvement.

• Own and manage QMS processes in accordance with ISO 13485 and regulatory standards;
• Act as a key contact for quality issues across SSP and global teams;
• Represent Stryker in internal and external audits;
• Lead and support Change Control, Nonconformances (NCs), and Corrective and Preventive Actions (CAPAs);
• Train and coach SSP personnel on quality processes and regulatory obligations;
• Maintain and update standard operating procedures and ensure compliant record keeping and documentation;
• Drive process improvement initiatives and stay informed on regulatory changes and educate.

• Working knowledge of regulatory frameworks and legislation in Australia and New Zealand;
• Experience analyzing and interpreting regulatory documentation;
• Strong time management and planning skills;
• Effective communication and stakeholder engagement abilities;
• Ability to build relationships across diverse team;
• Receptive to feedback and committed to personal growth.

• Prior experience in regulatory affairs or quality assurance;
• Experience in a regulated industry, ideally medical devices;
• Familiarity with Australian and international medical device regulations;
• Tertiary qualifications in science, engineering, or a related field.

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