Test Method Specialist, Quality Assurance Lifecycle Laboratory

Coloplast A/S; Denmark; On-site; DKK 600,000 - 820,000; Full time

Job summary

Coloplast A/S seeks a Test Method Specialist to act as the technical focal point for selected test methods and equipment in the Pilot Plant in Mørdrup, Denmark. You will troubleshoot, qualify, calibrate and upgrade equipment, while ensuring data traceability and compliant laboratory processes throughout the product lifecycle.

You will work closely with QA Lifecycle Laboratory and international manufacturing sites, coordinating improvements, audits and transfers, with strong stakeholder

Qualifications

• Master’s degree in science/engineering/technical field or 5+ years of relevant experience with test methods
• Hands-on experience with test methods and qualification of laboratory or production equipment
• Strong problem-solving skills and structured root cause analysis
• Confident evaluating and presenting technical data, including statistical methods
• Ability to write and interpret technical documentation, protocols and reports
• Knowledge of quality systems; ISO 9001/13485 and GMP understanding is advantageous
• Able to plan, prioritise work and see activities to completion
• Excellent stakeholder management across functions, sites and suppliers
• Proficient English; Danish is an advantage
• Experience with digital tools for documentation and traceability (Microsoft Office, Veeva, JMP)

Responsibilities

• Acting as technical owner and contact for test methods and equipment
• Plan, coordinate and perform qualification of test equipment, including relocations and replacements
• Prepare and maintain qualification protocols, reports and test method documentation
• Troubleshoot test equipment and methods; lead root cause investigations
• Ensure calibration, servicing, preventive maintenance and proper data traceability
• Handle changes, nonconformities and CAPAs related to test methods and equipment
• Support data handling and traceability before product release
• Coordinate transfers of methods/equipment to international sites
• Provide technical support to Pilot Plant, Global Operations and manufacturers
• Collaborate with Global Test Method teams on method development and improvements
• Train staff in test methods and equipment usage
• Coordinate software/PC upgrades and manage suppliers and service agreements
• Participate in audits related to test methods and equipment
• Contribute to continuous improvement of lab processes and systems

Skills

Test methods

Root cause analysis

Data analysis

Stakeholder management

Quality systems

Documentation

English communication

Education

Master's degree in science/engineering/physics/chemistry/pharmacy

Tools

Veeva

JMP

Office software

Job description

Imagine if robust test methods and reliable test equipment helped ensure the quality of both new and existing Coloplast products. That is where you come in.

As our new Test Method Specialist, you will become the technical focal point for selected test methods and related equipment in the Pilot Plant in Mørdrup, primarily supporting the QA Lifecycle Laboratory and Pilot SVS. This is a practical, hands-on specialist role in which you will work directly with laboratory equipment, including troubleshooting, service and calibration follow-up, qualification, and software and computer upgrades. You will support the full test method and equipment lifecycle, from implementation and qualification to maintenance, transfer and continuous improvement.

If you are motivated by hands-on technical problem-solving, equipment responsibility, quality assurance and data evaluation, this role offers meaningful responsibility and broad organisational impact. You will also work closely with many internal and external stakeholders, making clear communication, coordination and strong stakeholder management an important part of your success.

“In this role, your technical judgement and ability to create robust solutions will help ensure reliable test results and compliant laboratory processes throughout the product lifecycle,” says Lotte Stoklund, Team Manager, QA Lifecycle Laboratory.

Join a skilled and collaborative laboratory team
At our Coloplast Mørdrup site, you will join the Quality Assurance Lifecycle Laboratory. The team consists of laboratory technicians and test method specialists who work closely together to support ongoing production, process development, quality investigations and test method activities.

You will be part of an engaged team with a strong mix of practical laboratory experience and specialist knowledge. In our daily work, we collaborate closely with colleagues across Quality Assurance, Research and Development, Operations, Global Test Method teams and international manufacturing sites. We value curiosity, knowledge sharing, flexibility and a continuous improvement mindset.

Own and develop test methods and equipment
As Test Method Specialist, you will act as a one-point contact and technical superuser for selected test methods and test equipment. A significant part of the role is practical equipment responsibility. You will work hands-on with equipment and coordinate activities to ensure it is qualified, calibrated, serviced, maintained and performing as intended. You will also support software and computer upgrades connected to the equipment, as well as reliable data handling and traceability.

Your primary responsibilities will include:

• Acting as technical owner and one-point contact for selected test methods and related test equipment
• Planning, coordinating and performing qualification of test equipment, including relocation, capacity expansion and replacement of critical parts
• Preparing and maintaining qualification protocols, reports, procedures, test method documentation and one-point lessons when needed
• Performing hands-on troubleshooting of test equipment and methods, evaluating test results and leading root cause investigations when failures occur
• Taking practical responsibility for test equipment, including service activities, calibration follow-up, preventive maintenance and ensuring that equipment performs as intended
• Handling changes, nonconformities and CAPAs related to test methods, calibration and test 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 and sparring to colleagues in the Pilot Plant, Global Operations and international manufacturing sites
• Collaborating with Global Test Method teams and contributing technical input to the development and improvement of test methods
• Training specialists, laboratory technicians, operators and other users in test methods, test principles and use of equipment
• Coordinating software and computer upgrades for test equipment, assessing their impact on qualification and documentation, and managing suppliers, service visits and relevant service agreements
• Participating in internal and external audits related to test methods, equipment and documentation
• Contributing to continuous improvement of laboratory processes, systems and ways of working

Bring strong technical judgement and a quality mindset
To succeed in this position, you combine technical depth with a structured, practical and hands‑on approach. You enjoy working directly with equipment, take ownership and work systematically when resolving technical issues. You are comfortable making decisions based on data, risk and regulatory requirements.

The role involves close collaboration with many internal and external stakeholders, therefor you communicate clearly, coordinate effectively and are able to build strong working relationships across functions, sites and suppliers.

We imagine that you bring:

• A master’s degree within science, engineering, mechanics, physics, chemistry, pharmacy or a comparable technical field, or have at least five years of relevant experience with test methods
• Solid hands‑on experience with test methods, measurement principles and qualification of laboratory or production test equipment
• Strong problem‑solving skills and experience with structured root cause analysis
• Confident evaluating, analysing and presenting technical data skills, including the use of statistical methods
• Ability to write, review and understand technical documentation, protocols and reports
• Knowledge of quality systems and regulated environments; knowledge of ISO 9001, ISO 13485 and GMP is an advantage
• An understanding of validation, calibration, design control, specifications and process risk management
• Abitlity to plan and prioritise your work effectively and follow activities through to completion
• Strong stakeholder management skills and collaborate effectively across disciplines, functions, geographical locations and external suppliers
• Communicating skills professionally in English, both written and spoken; Danish is an advantage
• A comfortable competence using digital tools for documentation, data analysis and traceability; experience with Microsoft Office, Veeva, JMP or similar systems is an advantage

A specialist role with broad impact
This is a permanent specialist position in the QA Lifecycle Laboratory. The role has no direct reports and includes collaboration with international colleagues and manufacturing sites. Some travel may be expected in connection with transfers, supplier activities and site support.

You will join a working environment where quality, safety, technical excellence, knowledge sharing and continuous improvement are central to our daily work. You will have the opportunity to build a broad network and influence how test methods and equipment are managed across the product lifecycle.

Interested?
If you would like to know more about the position, please contact Lotte Stoklund, Team Manager, QA Lifecycle Laboratory, at [e-mail].

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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