Job summary
This role involves leading the closure and management of Corrective and Preventive Actions (CAPA), deviation, and change control records within specific sites or departments of a medical technology organization. The CAPA Leader drives timely, high-quality outcomes through project management, lean principles, structured problem solving, and collaboration across multiple functions including Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs. The role includes representing the organization in audits and may involve interaction with regulatory bodies.
Location and work setup
- Location
- Oslo
- Work setup
- On-site
Responsibilities
Lead execution and closure of CAPA, deviation, and change control records ensuring compliance with quality management systems and regulatory requirements. Manage and facilitate CAPA Review Boards, analyze trends and data to inform quality processes, and apply structured problem solving techniques to address complex quality issues. Ensure site audit readiness and support internal and external audits, representing the organization professionally. Use project management and lean methodologies to maintain robust quality outcomes and timely completion of quality tasks. Coach and develop colleagues within the quality organization as an individual contributor.
Qualifications
Bachelor's degree from an accredited institution. Significant experience in quality, manufacturing, or engineering within regulated industries such as medical devices or pharmaceuticals. Practical knowledge of quality management systems and regulatory requirements related to GMP. Skills in project management and lean methodologies, proficiency in use of quality event management systems, strong analytical and root cause analysis capabilities. Excellent communication and interpersonal skills with ability to collaborate across functions, lead change initiatives, and support audit processes.