Senior Quality Engineer – Design Assurance
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Skillsource is partnering with a leading global organisation in the medical technology sector to recruit a Senior Quality Engineer Design Assurance. This role supports both new product development and sustaining engineering ensuring products are designed developed changed and maintained in full alignment with global regulatory expectations and internal quality standards.
The successful candidate will act as the Quality representative on project core teams providing leadership on design control risk management and compliance throughout the product lifecycle. The position requires strong communication analytical capability and confidence in guiding crossfunctional teams through regulatory and quality expectations.
Role Purpose
As Senior Quality Engineer Design Assurance you will be responsible for applying Quality Engineering principles across multiple projects ensuring all design activities meet regulatory corporate and quality system requirements. You will support product development from concept through to launch and contribute to ongoing product improvement initiatives.
This role is central to driving a strong quality culture and ensuring that risk management design documentation verification and validation (V&V) and compliance deliverables are robust traceable and auditready.
Key Responsibilities
Design Assurance Leadership
- Act as the Design Assurance Quality Engineer on project core teams for both new product development and design change projects.
- Develop close working relationships with R&D Compliance Manufacturing Regulatory and extended Quality teams.
- Ensure design control processes are followed and documented appropriately throughout each project phase.
Design History File (DHF) & Documentation
- Contribute to the creation and maintenance of Design History File (DHF) documentation ensuring completeness and regulatory readiness.
- Review and approve V&V plans test protocols reports and supporting documentation.
Risk Management
- Lead risk management activities in accordance with ISO 14971.
- Support crossfunctional teams in applying robust risk assessment and mitigation practices.
- Ensure risk documentation is maintained traceable and consistent with product requirements and changes.
Compliance & Standards
- Support compliance activities relating to relevant medical device standards (e.g. electrical software usability).
- Partner with the Compliance function to drive adherence to applicable regulatory requirements such as IEC 60601 and IEC 62304.
- Ensure design changes meet global and corporate standards.
Verification Validation & Statistical Review
- Work with R&D to develop comprehensive testing strategies and V&V plans.
- Review challenge and approve test methodologies statistical approaches sample sizes acceptance criteria and rationales.
- Assess and authorise deviations associated with test execution.
Quality Investigations & Issue Management
- Lead or support failure investigations rootcause analysis and structured problemsolving initiatives.
- Manage and track software issues in alignment with IEC 62304 ensuring appropriate risk assessment and documented dispositions.
Quality Culture & CrossFunctional Influence
- Advocate for strong quality behaviours within project teams.
- Influence decisionmaking and escalate blocking issues when product quality or compliance is at risk.
Quality System Activities
- Contribute to broader QMS activities including:
- CAPA
- Field assessments
- Operations engineering evaluations
- General QMS compliance tasks
Candidate Profile
Essential Qualifications & Experience
- Degree in Engineering or related discipline or minimum 5 years relevant quality engineering experience.
- Strong knowledge of ISO 13485 QSR ISO 14971 and statistical techniques.
- Demonstrated expertise in design assurance including design controls compliance and risk management.
- Experience working within regulated medicaldevice environments.
- Strong organisational analytical written and verbal communication skills.
- Ability to influence crossfunctional teams and drive resolution of qualityrelated concerns.
Desirable Experience
- Working knowledge of MDR.
- Experience with IEC 62304 (medical software lifecycle) and IEC 62366 (usability engineering).
- Familiarity with documentation systems change control tools and qualitysystem software.
Working Model
This role requires strong onsite collaboration due to the nature of product development and crossfunctional interaction. A minimum presence of four days per week onsite is expected to support effective teamwork communication and problemsolving.
Contract Details
- Type: Fulltime
- Level: MidSenior
- Travel: Occasional
- Visa Sponsorship: Not available
- Security Clearance: Not required
Why Apply
This position offers an opportunity to be directly involved in shaping highimpact medical technologies. You will influence product quality and safety from concept to launch work with talented multidisciplinary teams and contribute to a culture that values innovation patient safety and continuous improvement.
Key Skills
- Continuous Integration
- APIs
- Jenkins
- Test Cases
- Performance Testing
- Quality Assurance
- Agile
- Jira
- Software Testing
- Java
- Test Automation
- Selenium
