Quality Lead

The Role

In your role as Quality Lead, you will champion quality throughout our organisation, contributing towards fulfilling our corporate mission of creating advanced technology products that positively impact our world. As a passionate Quality professional, you will ensure the effectiveness of our QMS by creating awareness of the value of Quality within the organisation. You will coordinate management team members to facilitate procedural compliance, overseeing, developing, and implementing our Quality Management System (QMS) and processes. You will share your experience and conduct training and induction of new staff, as well as ensure that relevant documentation stays up to date. Facilitating regulatory, risk and verification management activities on internal and external projects will be a key part of your role. You will conduct periodic audit activities and provide regular reports to senior management on all aspects of our QMS. As part of the company's growth strategy, you will identify suitable staff members to train as part of growing our quality management team.

Key Responsibilities

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 obal 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.

Skill and Experience

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 lead experience in product design and development.

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.

Only applicants who meet the required criteria will be contacted for the next stage.

*** No agencies for this role thank you ***