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Details
Location
Sydney
Salary / Hourly Rate
Job Type
Permanent Full-Time or Contract
The Role
Your key responsibilities in leading and supporting the Quality Management processes and team are:
Championing quality within the organisation, 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 co-ordinating 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.
Minimum Criteria
The following skills and experience are required for this role:
A relevant qualification from a reputable education organisation.
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 a variety of 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.
Preferred Skill And Experience
The following skills and experience are preferred for this role:
ISO 17955 Lead Auditor certified.
Quality management experience in product design and development.
Favorable Criteria
About Us
If you are passionate about creating innovative, human-centric products and want to do it as part of one of Australia's leading product design teams, this unique opportunity is for you! Work on a diverse range of products, showcase your excellence in design and bring cutting-edge products to life.
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, qualified designers and engineers to continue to develop their skills with us.
Location
Our Sydney office is located in the North Ryde technology area with convenient access by road and public transport.
We provide workplace flexibility by allowing staff to work from home for part of the week.
Seniority level
- Seniority levelMid-Senior level
Employment type
- Employment typeContract
Job function
- Job functionQuality Assurance
- IndustriesDesign Services
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📌 Quality Manager (Sydney)
🏢 Ingenuity Design Group
📍 Australia