Now Hiring: Design Assurance Quality Engineer (Mid–Senior Level) Location: Hybrid / Occasional Travel Function: Quality Engineering – Design Assurance Experience: 7–10 years | Bachelor's Degree minimum Are you a Quality Engineering professional passionate about shaping safe, compliant, and innovative medical technologies? This role offers the opportunity to influence product excellence from concept through launch — and beyond.
We're looking for a Design Assurance Quality Engineer to join a dynamic, cross-functional environment, partnering closely with R&D, Compliance, and Project Core Teams to ensure products meet the highest standards of safety, performance, and regulatory compliance.
About the Role As a Design Assurance QE, you will be deeply involved in both new product development and sustaining engineering projects, guiding teams through design controls, risk management, verification & validation, and compliance activities.
You will act as the Quality representative on project teams, ensuring that quality standards, global regulations, and engineering best practices are embedded at every stage of development.
This is a hands-on, influential role where strong communication, cross-functional collaboration, and a patient-first mindset are essential.
Key Responsibilities Serve as the Design Assurance Lead on project core teams for design changes and product development.
Contribute to and maintain Design History File (DHF) documentation.
Lead risk management activities, ensuring alignment with ISO 14971.
Drive compliance activities (e.g., IEC 60601, IEC in collaboration with the Compliance Engineer.
Champion a strong quality and patient-first culture across project teams.
Support development and review of verification & validation plans, protocols, and reports.
Review and challenge statistical justifications and data analyses.
Approve deviations and assess test execution issues.
Lead or support failure investigations and root cause analyses.
Oversee software issue tracking processes aligned to IEC 62304 requirements.
Ensure robust design control, risk management, and change control practices.
Contribute to broader QMS activities, including CAPA, Field Assessments, and operational quality assessments.
About You You will thrive in this role if you bring: A relevant engineering or scientific degree (or equivalent experience).7–10 years of experience in Quality Engineering within a regulated environment.
Strong knowledge of ISO 13485, QSR, ISO 14971, and key statistical techniques.
Proven expertise in design assurance, design controls, and regulatory standards.
Experience with IEC 62304 and/or IEC advantage).
Familiarity with MDR (advantage).
Excellent written and verbal communication skills.
Strong organisational capability and an ability to influence at all levels.
The ability to assess and escalate blocking issues appropriately.
Occasional travel availability.
Why This Role?Work at the centre of new product innovation.
Influence product safety, compliance, and technical excellence.
Collaborate with talented R&D, compliance, and quality professionals.
Engage in meaningful work that directly impacts patient safety and outcomes.
Interested or know someone who might be?Send a message or apply directly — we'd love to hear from you.
Planet Pharma is an equals opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age.