Innovation Quality Assurance: Process Risk Lead

Coloplast; Helsingør; Hybrid; DKK 650,000 - 850,000; Full time

Job summary

Coloplast in Denmark invites applications for a process risk specialist to shape manufacturing development with focus on quality and compliance from the start. You will balance innovation with regulatory requirements across R&D and Operations, partnering with cross-functional teams to build robust and scalable manufacturing systems.

Join a dynamic environment where nine colleagues share a passion for quality and safety, and where master’s-level expertise in STEM and MedTech experience are highly

Qualifications

• Master's degree in a STEM field required.
• Proven track record in project lead or quality roles.
• Operational experience in manufacturing or development.
• Extensive process risk management experience in MedTech.
• Fluent in English; Danish language preferred.

Responsibilities

• Own process risk assessments and implement mitigation actions.
• Define and maintain validation strategies for projects.
• Review validation docs, protocols and reports.
• Support change control and ensure validated states.
• Provide process expertise to R&D and Operations teams.
• Contribute to audits and inspections.
• Drive continuous improvement of quality systems.
• Develop and maintain quality procedures and internal standards.

Skills

Process risk management

Quality assurance

Project leadership

Operational experience

MedTech experience

English language

Danish language

Education

Master's in STEM

Job description

Coloplast in Denmark invites applications for a process risk specialist to shape manufacturing development with focus on quality and compliance from the start. You will balance innovation with regulatory requirements across R&D and Operations, partnering with cross-functional teams to build robust and scalable manufacturing systems.

Join a dynamic environment where nine colleagues share a passion for quality and safety, and where master’s-level expertise in STEM and MedTech experience are highly