Test Method Specialist – QA Lifecycle Lab

Coloplast; Mørdrup; Remote; DKK 600,000 - 800,000; Full time

Job summary

Coloplast is seeking a Test Method Specialist for the QA Lifecycle Laboratory in Denmark. The role focuses on owning and developing test methods and equipment, with hands-on responsibility for qualification, calibration, service and data handling, including software upgrades and cross-site transfers.

You will collaborate with Quality Assurance, R&D, Operations and Global Test Method teams, train users, and contribute to continuous improvement of laboratory processes and documentation.

Qualifications

• Master’s degree or at least five years of relevant experience with test methods.
• Hands-on experience with test methods and qualification of laboratory or production test equipment.
• Strong problem-solving skills and structured root cause analysis.
• Ability to write, review and understand technical documentation and reports.
• Knowledge of quality systems; ISO 9001, ISO 13485 and GMP is advantageous.
• Ability to plan and prioritise work and follow activities to completion.
• Strong stakeholder management and collaboration across disciplines and sites.
• English communication; Danish is an advantage.
• Experience with Microsoft Office, Veeva, JMP or similar systems is advantageous.

Responsibilities

• Acting as technical owner and one-point contact for selected test methods and related test equipment
• Planning, coordinating and performing qualification of test equipment
• Preparing and maintaining qualification protocols, reports and test method documentation
• Performing hands-on troubleshooting of test equipment and methods and leading root cause investigations
• Taking practical responsibility for test equipment, including service, calibration follow-up and preventive maintenance
• Handling changes, nonconformities and CAPAs related to test methods and equipment
• Supporting compliant storage and traceability of raw data before product release
• Planning and participating in transfers of test methods and equipment to international manufacturing sites
• Providing technical support to colleagues in Pilot Plant, Global Operations and international sites
• Collaborating with Global Test Method teams and improving test methods
• Training specialists and operators in test methods and equipment
• Coordinating software upgrades for test equipment and managing suppliers/service visits
• Participating in audits related to test methods, equipment and documentation
• Contributing to continuous improvement of laboratory processes

Skills

Test methods

Hands-on

Root cause analysis

Data analysis

Technical communication

Stakeholder management

Quality mindset

Problem solving

Education

Master’s degree or 5+ years experience

Tools

Microsoft Office

Veeva

JMP

Job description

Coloplast is seeking a Test Method Specialist for the QA Lifecycle Laboratory in Denmark. The role focuses on owning and developing test methods and equipment, with hands-on responsibility for qualification, calibration, service and data handling, including software upgrades and cross-site transfers.

You will collaborate with Quality Assurance, R&D, Operations and Global Test Method teams, train users, and contribute to continuous improvement of laboratory processes and documentation.