Test Method Specialist, Quality Assurance Lifecycle Laboratory

About the role

As a Test Method Specialist you will be the technical focal point for selected test methods and equipment in the QA Lifecycle Laboratory, supporting both new and existing Coloplast products. The role is hands‑on, covering equipment troubleshooting, service, calibration, qualification and software upgrades.

Key responsibilities

• Act as technical owner and one‑point contact for selected test methods and equipment.
• Plan, coordinate and perform qualification, relocation, capacity expansion and part replacement of test equipment.
• Prepare and maintain qualification protocols, reports and test method documentation.
• Troubleshoot equipment, evaluate test results and lead root‑cause investigations.
• Manage service activities, calibration follow‑up and preventive maintenance.
• Handle changes, non‑conformities and CAPAs related to methods and equipment.
• Support data traceability and storage prior to product release.
• Participate in method and equipment transfers to international sites and provide training.

Required profile

• Master’s degree in a scientific or engineering discipline or at least five years of relevant test‑method experience.
• Strong hands‑on experience with laboratory or production test equipment qualification.
• Proven problem‑solving skills and structured root‑cause analysis.
• Ability to make data‑driven decisions in regulated environments (ISO 9001, ISO 13485, GMP).
• Excellent communication in English; Danish is a plus.

Required skills

• Test equipment qualification and calibration.
• Root‑cause analysis and statistical data evaluation.
• Technical documentation, protocols and report writing.
• Knowledge of quality systems (ISO 9001, ISO 13485, GMP).
• Understanding of validation, design control and risk management.
• Proficiency with digital tools such as Microsoft Office, Veeva and JMP.