Process Risk Specialist - Quality & Innovation in Ops

Coloplast; Humlebæk; Hybrid; DKK 900,000 - 1,200,000; Full time

Job summary

Coloplast is seeking a Process Risk Specialist to join our manufacturing development site. You will lead process risk management initiatives, ensuring quality and compliance across the product lifecycle while collaborating with R&D and Operations teams.

Role combines elements of product development, process development, and operations to build robust, compliant manufacturing systems. Fluency in English is required; Danish preferred.

Qualifications

• Master’s degree in a STEM field.
• Background as a project lead or quality-related role.
• Operational experience.
• Experience with process risk management.
• MedTech experience.
• Fluent in English; Danish preferred.

Responsibilities

• Define and maintain validation strategies for processes and innovation projects.
• Review and approve validation documentation, protocols, and reports.
• Support change control activities and maintain validated states.
• Provide process expertise to project teams across R&D and Operations.
• Contribute to audits and inspections and drive quality system improvements.
• Develop and maintain quality procedures and internal standards.

Skills

Process risk management

Quality assurance

Stakeholder communication

Regulatory compliance

Quality systems

Education

Master’s degree in STEM

Job description

Coloplast is seeking a Process Risk Specialist to join our manufacturing development site. You will lead process risk management initiatives, ensuring quality and compliance across the product lifecycle while collaborating with R&D and Operations teams.

Role combines elements of product development, process development, and operations to build robust, compliant manufacturing systems. Fluency in English is required; Danish preferred.