Test Method Specialist, Quality Assurance Lifecycle Laboratory

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

Test Method Specialist, Quality Assurance Lifecycle Laboratory

Location: Espergærde, DK

Job Family: Quality Assurance

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, therefore 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
• Ability 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.

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.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark