Product Development Quality Assurance Manager
1 week ago
Your key responsibilities in leading and supporting quality management processes and teams are:
Championing quality within the organization, towards fulfilling our corporate mission.
Monitoring, maintaining and improving our purpose-built quality management system in accordance with ISO 13485 and ISO 9001 standards.
Ensuring overall compliance to standard operating procedures in line with the QMS.
Developing audit programs and plans, performing internal audits and coordinating external audits.
Identifying, planning and documenting opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
Managing and processing CAPA related activities.
Identifying and advising on relevant standards and regulation for product developments, maintaining up-to-date libraries of applicable standards and regulation across global markets.
Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
Facilitating appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.
Managing quality for the development of medical devices according to regulation such as CE MDR, FDA and TGA and standards including ISO 13485, IEC 60601 and IEC 62304.
Managing the calibration of test and measurement equipment.
Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
Developing and conducting induction and training on QMS processes and policies, and promoting QMS regulatory requirements to all staff.
Required Skills and Qualifications
- A relevant qualification from a reputable education institution.
- At least 5 years' experience in quality management or a similar role.
- In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
- Understanding of various production/manufacturing processes.
- Experience in communicating with and evaluating local and offshore suppliers.
- Excellent verbal and written English communication skills.
- Ability to work independently and as part of a team.
Benefits
We provide workplace flexibility by allowing staff to work from home.
Permanent and contractor roles are available.
About Us
We've created one of the largest multi-disciplinary product development consulting teams in Australia, and we're continuing to grow.
We provide comprehensive design services to leading Australian and international companies for a wide range of industries. These include consumer, commercial, sporting and leisure, industrial, automotive, bio-medical, mining applications and more.
Our development team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers and more. We provide a full turn-key service for our customers and a unique opportunity for creative, passionate, professional designers and engineers to continue to develop their skills with us.
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