Sr QA Engineer

Andocor

Andocor is a Belgian company active in the field of cardiovascular surgery and anesthesiology. At our site in Hoogstraten, we manufacture high-quality cardiac catheters and cannulae.

Our commitment to scientific research and our endeavor to excellence and quality have propelled Andocor to successfully market and sell our innovative line of cardiac catheters and cannulae worldwide. This success is a result of applying high standards of manufacturing methods, a highly-qualified scientists and production personnel and cooperating side by side with the specialists and doctors who are the ultimate judge of Andocor as their partner for better patients' care.

Job Description

Quality System Leadership

• Maintain and continuously improve the Quality Management System (QMS) in accordance with ISO 13485:2016 and MDR requirements.
• Assist internal and external quality audits , including Notified Body inspections and supplier audits.
• Ensure alignment of QMS documentation with MDR Annex IX and Annex XI requirements.
• Oversee CAPA , non-conformance , and change control processes to ensure timely resolution and compliance.

Regulatory Compliance

• Ensure product and process compliance with EU MDR 2017/745 , including Technical Documentation, Post-Market Surveillance (PMS), and Vigilance.
• Collaborate with Regulatory Affairs to support Notified Body submissions , renewals, and responses.
• Monitor regulatory changes and proactively implement updates to the QMS and product documentation.

Product Quality Oversight

• Support complaint handling , root cause analysis, and trending for continuous improvement.

Qualifications

• Bachelor’s or Master’s degree in engineering, life sciences, or quality management .
• Minimum 5 years of experience in QA roles within the medical device industry .
• Proven expertise in ISO 13485:2016 , EU MDR 2017/745 , and applicable standards (e.g., ISO 14971, IEC 62304).
• Experience with Class IIa/IIb or Class III devices and Notified Body interactions.
• Strong leadership, project management, and communication skills.
• Proficiency in QMS software and document control systems