Quality Assurance Leader — ISO 9001 & FDA Readiness

Merit Medical Systems; Netherlands; Remote; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Flexible working hours

Learning opportunities

Internships

Job summary

Merit Medical Systems, Maastricht (The Netherlands), seeks a Quality Manager to lead the Quality Assurance function, ensuring ISO 9001 compliance and practical quality systems across production, logistics, and leadership teams. The role emphasizes hands-on shop-floor presence and cross-functional partnership to embed quality in daily operations.

The ideal candidate will drive regulatory readiness, support external audits, and guide continuous improvement with Lean/Six Sigma approaches within a

Qualifications

• Bachelor’s degree or equivalent in Quality Engineering/Engineering/Science (NFQ Level 7+).
• At least nine years of work experience, with a minimum of four years in a related management role.
• Working knowledge of FDA regulations, MDR/EU 2017/745, ISO 13485 and related quality systems.

Responsibilities

• Oversee the direction and management of assigned quality assurance departments.
• Ensure compliance with ISO 9001 and applicable regulations.
• Collaborate with Senior Leadership to achieve Best In Class quality objectives.
• Lead customer interactions and external audits on quality matters.
• Maintain daily visibility on the shop floor to monitor processes and identify risks.
• Coordinate corrective and preventive actions to prevent recurrence.

Skills

Quality management

ISO 9001

Leadership

Audits

Education

Bachelor’s degree in Quality Engineering/Engineering/Science

Job description

Merit Medical Systems, Maastricht (The Netherlands), seeks a Quality Manager to lead the Quality Assurance function, ensuring ISO 9001 compliance and practical quality systems across production, logistics, and leadership teams. The role emphasizes hands-on shop-floor presence and cross-functional partnership to embed quality in daily operations.

The ideal candidate will drive regulatory readiness, support external audits, and guide continuous improvement with Lean/Six Sigma approaches within a