QA Engineer – Medical Devices & Regulatory Impact

elekta; Veenendaal; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Profit-sharing plan

40 days paid time off

Monthly social gathering

Active employee association

Job summary

Elekta in the Netherlands is seeking a Quality Assurance Engineer to support process owners, implementing process and system changes that strengthen the local quality management system. You will work across Engineering, Regulatory Affairs, Sales, and Manufacturing to translate regulatory expectations into practical business requirements.

As an advocate for quality, you will contribute to compliant, efficient ways of working, participate in external audits, prepare audit plans and reports, and

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in Quality, Regulatory Affairs or Engineering, preferably in a medical device environment.
• Knowledge of ISO 13485, ISO 14971, MDR/IVDR is preferred.

Responsibilities

• Contribute to projects and value streams to meet quality/regulatory requirements.
• Prepare monthly quality metrics and analyze data for improvement.
• Represent the organization in quality and operational processes and audits.

Skills

Quality management

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in Engineering

Tools

Lean Six Sigma

Quality tools

Job description

Elekta in the Netherlands is seeking a Quality Assurance Engineer to support process owners, implementing process and system changes that strengthen the local quality management system. You will work across Engineering, Regulatory Affairs, Sales, and Manufacturing to translate regulatory expectations into practical business requirements.

As an advocate for quality, you will contribute to compliant, efficient ways of working, participate in external audits, prepare audit plans and reports, and