Quality Assurance Specialist Medical Devices

1 week ago

Sydney, Australia PPD Search Full time

Be part of an inclusive culture of excellence
- Large, global corporate medical device company
- Definite opportunity for growth and career succession plan

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.

WHAT’S IN IT FOR YOU?
- 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.

THE JOB - ESSENTIAL FUNCTIONS PERFORMED
- This 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.
- The role is encouraged to be supportive, enthusiastic, and proactive in nature to work with team members and stakeholders in maintaining quality methodologies, systems, processes, and practices which meet company, customer, and regulatory requirements.
- The position assists the QA team in coordinating tasks and activities associated with quality projects, complaints, field actions, document control, audits, management review, training, supplier management and non-conformances and will work in project teams relating to continuous improvement initiatives and value improvement projects.
- You will complete and compile quality reports, metrics, key performance indicators and presentations and understand key quality processes and maintenance of currency to quality, regulatory requirements, global and local policies, and procedures.
- You will have a can-do attitude that goes above and beyond to demonstrate commitment to a quality culture, patient safety, product quality and core company values.

SKILLS & EXPERIENCE REQUIRED
- You will have 2-3 years’ experience in the medical device, healthcare or manufacturing industries or similar regulated environment.
- Bachelor of Science, STEM or a related degree, with experience in document writing, good documentation practices, compiling presentations and reports.
- Experience in working within a team environment, supporting projects and a basic understanding of Continuous Improvement and Project Management initiatives is preferred but not essential.
- A general understanding of Quality Management Systems (for example ISO13485 / 9001 or a similar standard) or working within a process driven environment is highly desirable.
- Experience of being involved in internal / external audits or managing non-conformances is desirable but not essential.
- Microsoft Office Suite intermediate (Excel, PowerPoint, Word).
- Excellent English written & verbal communication, full Australian work rights and vaccinated against Covid.

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