Process Risk Specialist

Job summary

The role involves ensuring that new products and processes meet quality and compliance standards before production. As a process risk specialist, you will be responsible for managing process risk assessments and implementing risk mitigation measures throughout the manufacturing system.

Qualifications

• Master's degree in a STEM field
• Experience in project lead or quality-related specialist roles
• Operational experience
• Proven track record in process risk management
• MedTech industry experience
• Fluent in English; proficiency in Danish is preferred

Responsibilities

• Conduct process risk assessments and ensure risk mitigation measures are implemented
• Define and maintain validation strategies for innovation projects
• Review and approve validation documentation, protocols, and reports
• Support change control activities and maintain validated states
• Provide process expertise to project teams and stakeholders
• Contribute to audits and inspections
• Drive continuous improvement of processes, templates, and quality systems
• Support the development and maintenance of quality procedures and internal standards

Skills

• Strong stakeholder engagement and communication skills
• Ability to thrive in a collaborative and dynamic environment
• Practical and solution-oriented mindset

Education

• Master's degree in a relevant STEM field

Tools

• Quality management systems and validation documentation