- Global, well established medical device company renowned for their surgical product innovation.
- They specialise in developing bespoke surgical solutions which make a difference and are known for their high quality and reliability.
- Very values driven organisation with an exceptionally supportive, hands on and collaborative team.
- Global, family-owned medtech company with a 120+ year legacy delivering cutting-edge surgical instruments, implants and operating-theatre solutions worldwide.
- Small, close knit team in an established company whose culture is very collaborative.
- A company that invests heavily in their people.
- As the Quality Manager you will be responsible for leading and overseeing the company’s entire quality management system, ensuring compliance with relevant regulatory standards and driving continuous improvement initiatives across all surgical products.
- Developing, implementing, and maintaining quality policies, procedures, and best practices to ensure the delivery of safe, reliable, and high-quality medical devices is key to this role.
- You will be managing and mentoring a small, collaborative quality team, fostering a culture of accountability, excellence, and continuous learning.
- You will be driving internal and external audits, inspections, and certification processes, including liaising with regulatory bodies to maintain compliance with global medical device regulations.
- Partnering with cross-functional teams, including R&D, manufacturing, and supply chain, to proactively identify and resolve quality issues while supporting product innovation is also important.
- You will be monitoring and analysing quality performance metrics, customer feedback, and risk assessments to implement corrective and preventative actions that enhance product reliability and patient safety.
- You will be championing a values-driven culture that aligns with the company’s mission, promoting a supportive, hands-on approach to problem-solving and collaborative decision-making.
- Minimum 3 years’ experience in a Quality Management or QA role, within the medical device/medtech sector.
- Strong knowledge and hands-on experience with Quality Management Systems (QMS) and eQMS, with proficiency in Microsoft Office, SAP, and Adobe.
- Excellent interpersonal, communication, and leadership skills, with the ability to manage multiple projects, work independently, and collaborate effectively within a team.
- Tertiary qualification in Engineering/Science or related discipline.
- Experience working in a quality assurance role within the medical device industry with a strong understanding of ISO 13485 and Good Manufacturing Practice (GMP) requirements.
- You must be vaccinated against COVID-19 and have full working rights for Australia.
- Must be able to work 5 days a week in Lane Cove West.