Senior Quality Engineer (Medical Devices, Remote)

Job summary

The role involves ensuring product and process quality in a medical device manufacturing environment, focusing on compliance with regulatory standards and continuous improvement initiatives.

Qualifications

• Degree in Engineering (Mechanical, Electronics, or related field)
• 8 years of experience in Quality Assurance or Quality Engineering within the medical device sector

Responsibilities

• Maintain and enhance the Quality Management System (QMS) in line with ISO 13485, FDA QMSR, and EU MDR requirements
• Support internal and external audits and regulatory inspections
• Oversee in-process and final inspections, ensuring compliance with GMP standards
• Investigate nonconformances, perform root cause analysis, and recommend corrective actions
• Lead CAPA investigations to address systemic issues
• Support process validation and risk assessments
• Analyze quality data to identify improvement opportunities

Skills

• Strong knowledge of ISO 13485, FDA QMSR, EU MDR
• Experience with NC and CAPA processes
• Familiarity with statistical tools (SPC, Six Sigma) and problem-solving methods
• Excellent communication skills in English and Danish

Education

• Degree in Engineering (Mechanical, Electronics, or related field)

Tools

• Experience with electronic QMS tools and validation processes is advantageous