Contract Quality Engineer

Location: Poland (On-site/Hybrid depending on site requirements)
Contract Type: Freelance Contract
Duration: Initial 12 months with extension potential

Overview

We are supporting a leading global medical device manufacturer in the search for an experienced Quality Engineer to join a high-performing quality team. This role will focus on supporting manufacturing operations, driving quality improvements, ensuring regulatory compliance, and participating in continuous improvement initiatives within a highly regulated environment.

Key Responsibilities

• Support manufacturing and operational quality activities across the site.
• Lead and support CAPA investigations, root cause analysis, and non-conformance management.
• Participate in quality improvement projects aimed at reducing defects and improving process performance.
• Support internal, external, and supplier audits.
• Ensure compliance with ISO 13485, MDR, and applicable regulatory requirements.
• Review and approve quality documentation, procedures, and records.
• Perform risk assessments and support implementation of risk mitigation activities.
• Support process validation activities (IQ/OQ/PQ) and ongoing manufacturing validation requirements.
• Analyse quality metrics and trends to identify opportunities for improvement.
• Work closely with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs teams on quality-related matters.

Requirements

• Degree in Engineering, Life Sciences, or a related technical discipline.
• Experience working as a Quality Engineer within the medical device, pharmaceutical, or other highly regulated industry.
• Strong knowledge of ISO 13485 and quality management systems.
• Experience with CAPA, NCRs, root cause analysis, and continuous improvement methodologies.
• Exposure to process validation and manufacturing quality activities.
• Experience supporting audits and regulatory compliance activities.
• Strong communication and stakeholder management skills.
• Ability to work effectively in cross-functional teams.

Preferred Experience

• Medical device manufacturing environment.
• Supplier Quality or Operations Quality experience.
• Experience with risk management methodologies such as FMEA.
• Knowledge of FDA regulations and EU MDR.
• ASQ CQE or equivalent quality certification.