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.
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