ABOUT WELLAND MEDICAL LTD:

Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world.
Welland Medical is a part of Clinimed Holdings Limited, a prominent figure in the Healthcare and Medical Equipment sector. Clinimed Holdings Limited comprises a group of companies established in 1982 through the acquisition and formation of various entities within the group.

JOB SUMMARY:

The Junior QA Engineer serves as a key liaison across departments, helping ensure all products and processes comply with ISO 13485 and Medical Device Regulation (EU) 2017/745.
Key responsibilities include managing material issues, coordinating with the Procurement team and suppliers for timely resolution, overseeing calibration and testing requirements, and supporting the validation schedule.
This role promotes strong collaboration between Quality, Regulatory, Engineering, Procurement, Production, and Planning, driving continuous improvement and regulatory compliance across operations.

MAIN DUTIES & RESPONSIBILITIES:

• Ensure adherence to the Quality Management System (QMS) and maintain compliance with ISO 13485 requirements.
• Perform calibration of production equipment as needed and maintain the calibration database.
• Monitor and report on quality metrics.
• Support Manufacturing in resolving quality and material issues promptly.
• Assist with validation activities for new materials, equipment, computer system validation (CSV), and processes.
• Contribute to the continuous improvement of the QMS in line with ISO 13485.
• Support training of site staff on Quality System procedures as required.
• Assist in managing Corrective and Preventive Actions (CAPAs) and support teams in closing CAPAs and non-conformances.
• Provide QA support and approval for CAPAs and non-conformance reports.
• Participate in internal and supplier audits, ensuring compliance with ISO 13485.
• Support the logging, tracking, and closure of internal and supplier audit actions.
• Collaborate with Operations, Engineering, and Planning teams to support and drive achievement of key manufacturing KPIs.

OTHER DUTIES:

• Support the investigation and reporting of customer complaints.
• Assist with incoming inspection, including sampling and analysis of raw materials.
• Contribute to Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
• Participate in Lean Manufacturing projects and provide progress updates to the Continuous Improvement (CI) Management team in relation to key KPIs.