PROCES VALIDATION ENGINEER FOR °MEQU

MEQU Warmer Systems Corp.; København; On-site; DKK 650,000 - 900,000; Full time

Benefits offered by this job

Influence work processes

Growth in MedTech career

International collaboration

Continuous learning culture

Job summary

MEQU Warmer Systems Corp. in Copenhagen seeks an experienced Process Validation Engineer to join the Operations Department and drive robust validation across production processes.

You will partner with R&D, Manufacturing, QA, and suppliers to implement IQ/OQ/PQ protocols, analyze data with DOE/SPC, and ensure compliance with ISO 13485, FDA and MDR standards.

Qualifications

• Bachelor’s or Master’s degree in engineering (Mechanical, Industrial, Biomedical, or related field).
• 3-5 years of proven experience in supplier quality engineering, process validation, or manufacturing engineering within MedTech, pharma, or other regulated industries.
• Strong knowledge of validation methodologies, statistical tools, and regulatory standards (ISO 13485, 21 CFR Part 11/820).
• Excellent problem-solving, analytical, IT and communication skills (English; Danish a plus).
• Experience with supplier management, audits, and CAPA processes is a plus.
• Driving license and ability to travel (MEQU have suppliers in Denmark and abroad).
• As a person, you enjoy working independently, trying new things, and managing a working day with deadlines and changeability.

Responsibilities

• Partner with R&D, Manufacturing, and Quality Assurance to ensure robust design transfer and/or capacity increase with validated production processes.
• Collaborate with suppliers and cross-functional teams to resolve quality issues and ensure compliance with regulatory requirements (ISO 13485, FDA, MDR).
• Develop, maintain, and execute the company’s Process Validation Master Plan, including IQ, OQ, PQ activities.
• Apply engineering and statistical methods (DOE, SPC, capability analysis) to evaluate processes and drive continuous improvement.
• Support risk management activities (FMEA, risk assessments) related to supplier performance and process validation.
• Ensure timely documentation and reporting in line with internal quality systems and regulatory expectations.
• Assisting the complaints and deviation handling processes

Skills

Process validation

Regulatory knowledge

Statistical tools

Problem solving

English communication

Danish language

Education

Bachelor’s or Master’s degree in engineering

Tools

DOE

SPC

CAPA

IQ/OQ/PQ

Job description

About the Role

Join °MEQU as we embark on an exciting growth journey and seek a new Process Validation Engineer for our Operations Department.

Seize this opportunity if you want to be part of our dynamic team in Copenhagen and help us shape the future of critical care.

At °MEQU we empower healthcare professionals to combat hypothermia and save lives with our innovative °M Warmer System; a portable blood and IV fluid warmer that heats fluids to body temperature within seconds. Used by military forces, emergency medical services, rescue helicopters, and hospitals globally, our system is trusted in the most demanding environments. We achieved CE-marking in 2018 and U.S. FDA 510(k) clearance in May 2024. As we continue our growth and expand into new markets, we are committed to delivering cutting-edge, user-friendly healthcare solutions.

We have offices at Symbion, Fruebjergvej 3, 2100 Østerbro.

Key Responsibilities

• Partner with R&D, Manufacturing, and Quality Assurance to ensure robust design transfer and/or capacity increase with validated production processes.
• Collaborate with suppliers and cross-functional teams to resolve quality issues and ensure compliance with regulatory requirements (ISO 13485, FDA, MDR).
• Develop, maintain, and execute the company’s Process Validation Master Plan, including IQ, OQ, PQ activities.
• Apply engineering and statistical methods (DOE, SPC, capability analysis) to evaluate processes and drive continuous improvement.
• Support risk management activities (FMEA, risk assessments) related to supplier performance and process validation.
• Ensure timely documentation and reporting in line with internal quality systems and regulatory expectations.
• Assistingthe complaints and deviation handling processes

ABOUT YOU

You have several years of experience from a similar position within process validation. Ideally from a company within the MedTech business, however as a minimum from a similar, strongly regulated high-tech business environment.

You are now ready to join a young and vibrant MedTech scale-up and contribute to the fast development of our Supplier Quality & Process Validation.

Qualifications

• Bachelor’s or Master’s degree in engineering (Mechanical, Industrial, Biomedical, or related field).
• 3-5 years of proven experience in supplier quality engineering, process validation, or manufacturing engineering within MedTech, pharma, or other regulated industries.
• Strong knowledge of validation methodologies, statistical tools, and regulatory standards (ISO 13485, 21 CFR Part 11/820).
• Excellent problem-solving, analytical, it- and communication skills (English and if also Danish, it’s a plus).
• Experience with supplier management, audits, and CAPA processes will be a plus
• Driving license and ability to travel (MEQU have suppliers in Denmark and abroad)
• As a person, you enjoy working independently, trying new things, and managing a working day with deadlines and changeability.

What We Offer

• A newly created position with the possibility to influence work processes and planning yourselves.
• The opportunity to shape supplier quality and validation processes in a growing MedTech company.
• Collaboration with international teams and exposure to innovative medical technologies.
• A culture of continuous learning, improvement, and patient-first focus.

Mequ is characterized by a strong culture of cross-functional collaboration and a striving to optimize working processes. In this role, you will work closely with Q&A, Regulatory, Research & Development and Production.

Since the company is undergoing a development with increased growth, it must be expected that the job description can be continuously adjusted with more and/or other tasks.