Cylite is an exciting, well funded, start-up company developing innovative optical imaging technologies and medical devices. The company is based in Melbourne, Australia, adjacent to the Monash University Science and Technology Precinct. We are looking for a Quality Manager with strong medical device experience to manage our quality team.
About the Role: The Quality Manager has overall responsibility for ensuring that the Cylite Quality Management System and products comply with applicable domestic and international medical device quality requirements. You will work with members of the engineering and production team to ensure that a quality culture is built into all levels of the business.
Required Skills: Experience with implementation and management of quality systems in accordance with ISO13485 and FDA QSR 21CFR820. Experience with medical device standards and CE, TGA, FDA device approval processes. Familiarity with IEC 62304 and IEC 60601-1 compliance processes is highly desirable. The ideal candidate will have the ability to understand complex medical/scientific technology and communicate with both product engineers and regulators.
The Quality Manager oversees the delivery of Cylite’s ISO 13485 certification and works with the Regulatory Manager to ensure systems and documentation are complete with MDD/MDR, TGA, FDA and other relevant regulatory certifications.
Main Duties include:
- Perform responsibilities and authorities of the Quality Management System Management Representative.
- Manage the Cylite Quality Management System and work to achieve a corporate culture of quality appropriate for a medical instrumentation development and manufacturing company.
- Work with the Optical, Mechanical, Electronics, Software and Production engineers to establish appropriate processes and documentation to enable certification of Cylite products in various regulatory environments.
- Manage systems for handling of any issues affecting the quality of Cylite products or product developments.
- Ensure timely identification of quality issues and work to ensure a timely resolution.
- Management of staff as requested by the Executive and Directors of the Company.
- Ensuring that processes needed for the QMS are established, implemented, and maintained.
- Reporting to Cylite Management on the performance of the QMS and any need for improvement.
- Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
- Conducting Management Review meetings, regulatory reporting, coordinating production recalls and corrections, and reporting regularly on all aspects of the Quality Management System.
Cylite is an Equal Opportunity Employer and embraces diversity and inclusion.
- What's your expected annual base salary?
- Which of the following statements best describes your right to work in Australia?
- How would you rate your English language skills?
- How many years' experience do you have as a Quality Manager?
Report this job advert
Learn how to protect yourself here.