The Company
The client is a medical technology company specializing in synthetic surgical hemostats and sealants. They are a part of an American global medical devices and pharmaceutical group.
Role Description
The client is seeking a Calibration Engineer to join its Nijmegen site. Reporting to the Engineering Manager, this role is responsible for ensuring full calibration compliance of production and measurement equipment used in the manufacture of medical and other high-precision devices. The Calibration Engineer maintains and optimizes the calibration system, performs hands-on calibration activities, supports equipment maintenance, and contributes to continuous improvement across operations. This position plays a key role in safeguarding audit readiness, equipment reliability, and regulatory compliance.
Responsibilities
- Ensuring timely, compliant, and consistent calibration of all assets in line with internal specifications and procedures.
- Developing and maintaining a master calibration schedule while minimizing impact on daily operations.
- Prioritizing, arrange, and document calibrating work orders - handled either internally or by external suppliers.
- Assessing gage status based on calibration results, apply proper labeling, and segregate non-conforming or overdue gages.
- Performing calibration procedures accurately using appropriate standards and tools.
- Maintaining calibration records in Maximo and managing calibration/qualification activities for new equipment.
- Maintaining and updating local calibration procedures, templates, and documentation.
- Analyzing calibration data, confirm calibration intervals, and strengthening the reliability of the calibration system.
- Developing in-house calibration capabilities and supporting new calibration methods or initiatives.
- Managing spare parts inventory for calibrated equipment and ensure new instruments meet system requirements.
- Supporting internal and external audits and maintaining an audit-ready calibration environment.
- Contributing to development and execution of preventive maintenance plans to ensure reliable equipment performance.
- Supporting troubleshooting, root cause analysis, and corrective actions for calibration- or equipment-related issues.
- Identifying improvement opportunities within calibration and engineering processes and assist with implementation.
- Creating and supporting calibration-related non-conformances and CAPAs.
- Complying with GMP, ISO standards, safety rules, records management policies, and all client operational guidelines.
- Ensuring continuous audit readiness and adherence to all applicable regulations.
- Communicating relevant business issues or opportunities to management.
- Collaborating effectively with internal teams and external vendors.
Requirements
- Bachelor’s degree in Engineering (Mechanical, Electrical, Electromechanical, Electronics, Metrology, Instrumentation preferred).
- 4–6 years of related experience, including 3–5 years in calibration and metrology.
- Experience in the medical device, pharmaceutical, or medical industry; GMP/ISO 13485 knowledge preferred.
- Strong understanding of calibration principles, measurement systems, and metrology.
- Ability to interpret vendor maintenance, calibration, and qualification reports.
- Proficiency with ERP systems, Maximo, and quality/documentation systems.
- Skilled in troubleshooting, data analysis, and problem-solving.
- Competent in standard office software (word processing, spreadsheets, data management).
- Fluent in English (written and spoken); Dutch is an advantage.
- Ability to explain complex technical concepts clearly to various stakeholders.
- Strong collaboration, organizational, and leadership capabilities.
- Proven ability to build trust and strong working relationships across teams.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
57545
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