Hands-On Test Method Specialist – QA Lifecycle Lab

Coloplast; Tibberup; On-site; DKK 700,000 - 860,000; Full time

Job summary

Coloplast is seeking a Test Method Specialist for the QA Lifecycle Laboratory at the Mørdrup site. You will act as the technical focal point for test methods and equipment, ensuring qualification, calibration and data traceability throughout the product lifecycle.

You will collaborate across Quality Assurance, R&D and Global Test Method teams, with hands-on responsibilities and opportunities to influence continuous improvement and regulatory compliance.

Qualifications

• Master's degree in science, engineering, mechanics, physics, chemistry, pharmacy or a comparable technical field.
• Five years of relevant experience with test methods is preferred.
• Hands-on experience with test methods and qualification of lab or production equipment.
• Strong problem-solving skills and structured root cause analysis.
• Ability to write, review and understand technical documentation, protocols and reports.
• Knowledge of quality systems; ISO 9001/13485 and GMP is advantageous.

Responsibilities

• Act as technical owner and one-point contact for selected test methods and related equipment.
• Plan and perform qualification of test equipment, including relocation and component replacement.
• Prepare and maintain qualification protocols, reports, and test method documentation.
• Troubleshoot test equipment and methods, evaluate results and lead root cause investigations.
• Coordinate software upgrades and ensure data traceability and documentation.

Skills

Test methods

Equipment qualification

Root cause analysis

Data analysis

Technical documentation

Stakeholder management

English proficiency

Education

Master's degree

Tools

Microsoft Office

Veeva

JMP

Job description

Coloplast is seeking a Test Method Specialist for the QA Lifecycle Laboratory at the Mørdrup site. You will act as the technical focal point for test methods and equipment, ensuring qualification, calibration and data traceability throughout the product lifecycle.

You will collaborate across Quality Assurance, R&D and Global Test Method teams, with hands-on responsibilities and opportunities to influence continuous improvement and regulatory compliance.