Quality Engineer

Medical Device Quality Engineer - 6 months

Location: Prague, Czech Republic

Contract Length: 6 Months (Potential Extension)

Start Date: ASAP

Working Pattern: 3 Days Onsite / 2 Days Remote

Company Overview

Our client is a leading global medical device organisation seeking an experienced Quality Engineer to support critical Quality Management System (QMS) initiatives at their Prague site.

This role will play a key part in supporting ongoing QMS implementation activities, audit readiness, certification efforts, and MDR compliance projects across the European business.

Responsibilities

• Support execution and continuous improvement of Quality Management System (QMS) processes.
• Assist with quality activities relating to distribution operations and associated procedures.
• Develop, monitor, and report quality KPIs and metrics.
• Partner closely with Quality and Regulatory Affairs teams to drive compliance initiatives.
• Support ISO 13485 compliance and quality system maintenance activities.
• Contribute to audit preparation, certification activities, CAPA management, and quality investigations as required.
• Support MDR readiness projects and wider quality improvement programmes.
• Ensure quality documentation remains accurate, compliant, and up to date.
• Collaborate with cross-functional stakeholders to drive quality excellence across the business.

Requirements

• Minimum 5 years' experience within the medical device industry.
• Proven experience working within a Quality Engineering or Quality Assurance function.
• Strong understanding of ISO 13485 and medical device quality systems.
• Experience supporting QMS implementation, maintenance, or remediation projects.
• Familiarity with CAPA, non-conformances, audits, change controls, and quality documentation.
• Fluent English communication skills.
• Ability to work independently and manage competing priorities within a fast-paced environment.

Desired Personal Attributes

• Proactive and solutions-focused mindset.
• Strong interpersonal and communication skills.
• Highly collaborative and sociable approach.
• Able to build relationships quickly across teams and stakeholders.
• Comfortable working autonomously with minimal supervision.
• Adaptable and capable of supporting a busy, evolving environment.

What's on Offer

• Opportunity to support a major medical device company during a critical phase of growth and quality transformation.
• Exposure to high-profile QMS implementation and MDR readiness projects.
• Flexible hybrid working model.
• Competitive day rate.
• Potential for contract extension based on project requirements and performance.