Senior Quality Engineer - Design Assurance

Team Horizon is seeking a Senior Quality Engineer Design Assurance for a global Med Tech company. Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes while driving adherence to global regulatory requirements. Your responsibilities will span from product inception through launch and maintenance, requiring strong collaboration with cross-functional teams and effective communication skills.

Why you should apply:

• You will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards.


• Join a company where imagination and passion,  design and engineering find transformative solutions that turn dreams into possibilities.

What you will be doing:

• 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.

What you need to apply:

• 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.