THE COMPANY YOU WOULD BE JOINING
- Leading, global innovator of medical devices and technologies that improve patient lives.
- Their mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures.
- As a member of the team, you'll be part of an inclusive culture of excellence, where you're encouraged to learn and grow, working to create and promote products and therapies that help improve the quality of patients' lives.
- You'll be part of something that's changing and growing, renewing capabilities all the time with new and diverse ideas and people.
- Although local in Australia, you will be part of a global team, with a winning mindset and extraordinary culture that encourages personal and professional growth.
- This Senior Quality Specialist position is responsible for ensuring processes are followed, improvements are implemented and supports awareness, visibility, and communication on quality initiatives across the ANZ organisation.
- In this role, you will champion patient safety and product quality by ensuring compliance with the Quality Management System.
- You will be responsible for representing this organisation with regulators, customers, and industry bodies.
- In this role, you will provide quality leadership and direction across cross-functional teams and business units.
- You will be responsible for driving key quality initiatives and value improvement projects that reduce risk and boost efficiency.
- In this role, you will collaborate across ANZ, APAC, and global teams to influence quality outcomes and support business growth.
- 8+ years’ experience in the medical device, healthcare or similar regulated industry
- Previous experience in a supervisory, manager role or the ability to demonstrate mentoring/coaching of team
- Bachelors in STEM or a similar related degree
- Experience in facilitating external audits with certifying organisations and/or regulators.
- Subject Matter Expertise of regulations and core processes relating to Quality Systems (for example,CAPA, Nonconforming product/process, Supplier Management, Supply Chain Operations, Regulatory Approvals, Auditing, Post Market, Complaints, Field actions, Customer Feedback / Satisfaction)
- Experience leading projects, continuous improvement initiatives, Value Improvements (VIP) using Project Management and/or Lean/6-Sigma principles.
- Strong problem solving, organisational and execution skills.
- High attention to detail and a collaborative approach.
- Excellent English written & verbal communication, full Australian work rights and vaccinated against Covid.