Quality Assurance Engineer – Medical Devices

IMDS; Roden; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

International environment

Challenging role

Training opportunities

Year-end bonus

Job summary

IMDS (Interventional Medical Device Solutions) in Roden, The Netherlands, is seeking a Quality Assurance Engineer to drive compliance across operations and New Product Development. You will review protocols, documents, and records while supporting CAPA, non-conformances, and internal audits in a multi-disciplinary setting.

The role requires a BSc/MSc in a relevant field, at least 2 years of medical device QA experience, and strong communication with manufacturing and development engineers.

Qualifications

• Clear and effective communication with cross-functional teams.
• Demonstrates ownership and accountability for quality outcomes.
• Ability to align cross-functional team members through collaboration.
• Strong written and oral English reporting and presentations.

Responsibilities

• Review of Engineering, Qualification- and Validation protocols and reports.
• Review of New Product Development documentation.
• Review of Specifications, Calibration- and Maintenance records.
• Maintenance of Quality Management Procedures, – Guidance’s and – Templates.
• Prepare and organize the Quality Management System Review meetings.
• Coordinate handling of Non-Conformance Records, CAPA’s and complaint investigations.
• Coordinate Cleanroom Monitoring and Corrective Actions.
• Coordinate Bioburden Monitoring, Endotoxin Monitoring and Periodic Dose Audits.
• Train new employees on Quality Management System.
• Prepare and execute internal audits (ISO 13485, cGMP) and DHF audits.

Skills

Communication

Ownership

Cross-functional collaboration

English reporting

Education

BSc/MSc in exact sciences

Job description

IMDS (Interventional Medical Device Solutions) in Roden, The Netherlands, is seeking a Quality Assurance Engineer to drive compliance across operations and New Product Development. You will review protocols, documents, and records while supporting CAPA, non-conformances, and internal audits in a multi-disciplinary setting.

The role requires a BSc/MSc in a relevant field, at least 2 years of medical device QA experience, and strong communication with manufacturing and development engineers.