Quality Engineer (18-month contract)

What you will do

The Quality Engineer is specifically assigned to establish, enhance, and maintain the quality system within the framework of designated projects. The primary goal of this role is to ensure the ongoing maintenance of the quality system to ensure the delivery of products that meet customer specifications and adhere to relevant regulatory standards within the project scope. Additionally, the QE is responsible for regularly monitoring and updating Quality key process indicators and leading projects aimed at achieving strategic goals and objectives within the context of the assigned projects.

Main responsabilities:

• Implement inspection plans for components and finished goods, including incoming material inspections and identification/segregation of nonconforming products, ensuring compliance with project requirements, GMP, and applicable regulations.
• Perform MSA (Measurement Systems Analysis) and ensure accurate inspection/calibration of monitoring and measuring devices, supporting inspection implementation and product quality control within the project scope.
• Lead and support the resolution of quality issues during the project, including the opening and closure of CAPAs, ensuring timely, effective responses and alignment with project-specific procedures and regulatory standards.
• Maintain and update standard quality system procedures based on continuous improvement, customer feedback, KPI trend analysis, and preventive/corrective actions related to the project.
• Lead or participate in internal and external quality system audits, focusing on project-related processes, ensuring compliance and identifying areas for improvement.
• Support and lead activities related to product and process changes (IQ, OQ, PQ), change control management, and document control, including NPI discussions and master validation plans for the project.
• Lead or collaborate in deploying quality and process tools such as PFMEA, control plans, R&R, PDCA, RCA, SPC, Cpk, etc., tailored to the project’s specific needs.
• Engage in general continuous improvement initiatives within the project, actively contributing to quality system enhancements and the achievement of project objectives.

What you need

• Bachelor's degree in engineering is required
• ASQ CQE or six sigma GB certification preferred
• Minimum of 3 years of experience in similar roll in a medical device manufacturing environment required.
• Considerable experience of quality systems for medical devices.
• Proficient in MS Office Suite (including Word, Excel and Power Point)
• Good knowledge of ISO 13485, CFR 820 and applicable regulatory requirements.
• Minitab and SAP knowledge is a plus.
• Conversational & Written English is required.
• Must be available for an 18-month fixed-term contract.