EER Poland, for one of our international clients operating in the medical devices manufacturing industry, we are currently looking for an experienced Quality Director / QA Manager who will take full ownership of the Quality Management System and ensure compliance with ISO 13485 standards.

This is a key leadership role within a regulated production environment where product quality, patient safety, and regulatory compliance are critical. The successful candidate will lead the quality function, manage audits, and drive continuous improvement across manufacturing processes, supplier management, and internal quality systems.

Quality Director / QA Manager (ISO 13485 – Medical Devices)

Location: On-site | Romania

Your Role

As the Quality Director / QA Manager, you will be responsible for developing, maintaining, and continuously improving the Quality Management System (QMS) in accordance with ISO 13485 and other applicable regulatory requirements.

You will work closely with production, operations, and management teams to ensure that all processes meet the highest quality and compliance standards expected in the medical devices sector.

Key Responsibilities

Quality Management System

• Lead and maintain the ISO 13485 compliant Quality Management System
• Define, update, and implement quality policies, procedures, and work instructions
• Ensure proper documentation control, traceability, and record management
• Align quality processes with operational and business objectives

Audits & Compliance

• Plan and lead internal audit programs
• Coordinate external audits and certification processes
• Ensure continuous audit readiness and regulatory compliance

Non-Conformities & CAPA

• Manage non-conformities, deviations, and product quality issues
• Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA)
• Monitor quality trends and drive improvement initiatives

Change Control & Validation

• Lead change control processes including compliance and risk assessment
• Coordinate validation and qualification activities (IQ/OQ/PQ) where required
• Ensure equipment and processes remain compliant with regulatory standards

Supplier Quality & Product Release

• Define and manage supplier qualification and performance monitoring
• Oversee incoming, in-process, and final quality control
• Approve product and material release according to internal quality procedures

Training & Governance

• Implement quality training programs
• Maintain training compliance and documentation
• Support management reviews and quality performance reporting

In this role you will have significant authority within the quality function, including:

• Stop-shipment authority in case of quality or compliance risks
• Ability to initiate CAPA, internal audits, or supplier re-evaluations
• Authority to escalate quality risks and request corrective actions across departments

What We Are Looking For

Experience

• Minimum 5 years of experience in Quality / QA / QMS roles
• Experience within regulated manufacturing environments, ideally medical devices
• Practical experience working with ISO 13485

Education

• University degree in Engineering, Technical, or Management discipline

Skills

• Strong leadership and communication skills
• Experience in root cause analysis and problem solving
• Ability to work in cross-functional and international environments
• Professional English

Why This Opportunity?

• Key leadership role in a growing medical device manufacturing environment
• Opportunity to shape and strengthen quality processes
• Direct impact on regulatory compliance, operational excellence, and patient safety
• International collaboration within a structured quality framework

If you are an experienced quality leader in regulated manufacturing looking for your next challenge, we would be happy to speak with you.

Show more
Show less