Junior Quality Engineer – Medical Devices

About the role

We are seeking a Junior Quality Engineer to join an innovative medical technology company. You will work in a regulated environment, supporting quality and compliance activities across the product lifecycle.

Key responsibilities

• Review and approve manufacturing batch records ensuring regulatory compliance.
• Support incoming inspection, including certificates, inspection reports, and material documentation.
• Participate in non‑conformance investigations, root‑cause analysis and CAPA implementation.
• Assist with equipment qualification and process validation (IQ/OQ/PQ) at supplier and manufacturing sites.
• Maintain quality compliance with ISO 13485, FDA, MDR and internal QMS.
• Collaborate with Regulatory Affairs, Procurement, Manufacturing and Quality teams.
• Take part in supplier audits, readiness assessments and continuous‑improvement initiatives.

Required profile

• Bachelor’s or Master’s degree in Engineering, Life Sciences or a related technical field.
• 3‑5 years of experience in quality operations within medical devices or another regulated industry.
• Knowledge of ISO 13485, FDA Quality System Regulations and GxP requirements.
• Experience working with suppliers and contract manufacturers.
• Familiarity with NC, CAPA, batch‑record review, validation activities and risk‑management methodologies.

Required skills

• ISO 13485
• FDA Quality System Regulations
• GxP compliance
• Non‑conformance (NC) investigation
• CAPA implementation
• Batch record review
• Equipment qualification (IQ/OQ/PQ)
• Process validation
• Risk‑management methodologies
• Electronic quality management systems (asset)

What we offer

• Opportunity to join a growing, innovative MedTech organization.
• Exposure to a broad range of quality‑operations activities and international stakeholders.
• Collaborative environment focused on innovation, quality and continuous improvement.
• Competitive compensation package and strong career‑development opportunities.