Senior Quality Engineer - Design Assurance

Senior Quality Engineer - Design Assurance.

As a Senior Design Assurance Quality Engineer you will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards. 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.

You will lead risk management activities, manage Design History File (DHF) documentation, and support compliance initiatives such as IEC 60601 and IEC 62304. The role involves reviewing and approving verification and validation plans, challenging statistical rationales, and authorizing deviations. You will also assist in failure investigations, software issue tracking, and advocate for a strong quality culture across projects. Additionally, you will contribute to broader Quality Management System (QMS) activities, including CAPA, field assessments, and operational engineering evaluations.

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 position 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.

Interested applicants should have:
• A relevant degree or equivalent experience (engineering degree preferred), or a minimum of 5 years' 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 an advantage
• Experience with IEC 62304 and IEC 62366 an advantage