About the role
As Quality Engineer - Design Assurance, you will be involved in new product development and product sustaining projects through the application of Quality Engineering skills. You will balance multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.
You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements. The Design Assurance QE represents the Quality Function on the Project core teams for both new product development and existing products.
Main responsibilities will include:
- Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with core team members and extended quality functions as needed for the project.
- Contribute to the formation and ongoing management of DHF documentation
- Lead risk management activities within the project.
- Drive compliance management activities (e.g., IEC 60601) on the project with support from the Compliance Engineer.
- Demonstrate a patient-first approach to quality engineering.
- Support the creation and implementation of verification and validation activities.
- Work closely with R&D functions to ensure comprehensive testing of product requirements and the execution of the V&V plan.
- Review and approve testing procedures and documentation.
- Review and challenge the statistical rationale and data analysis within the test protocol and reports.
- Assess and authorise related execution deviations.
- Assist/conduct Failure investigations and problem-solving sessions.
- Responsible for the software issue tracking process per IEC 62304 to ensure software issues are logged, risk assessed and dispositioned appropriately.
- Ensure compliance across projects for design control, risk management, and change control processes.
- Advocate for a strong quality culture within project core teams
- Support of other QMS activities outside of projects, such as CAPA, Field Assessment and operations engineering assessments.
About you
- A relevant degree or equivalent experience (engineering degree preferred), or a minimum of 5 years of quality engineering experience as an equivalent qualification
- Knowledge in working with ISO 13485, QSR, ISO 14971, and statistical techniques
- Expertise in design assurance, including design controls, standards compliance, and risk management
- Strong written and verbal communication skills
- Strong organisational skills
- Experience with MDR – advantage
- Experience with IEC 62304 and IEC 62366 – advantage
- Ability to influence. Assess the situation and determine if a blocking issue is triggered
