Overview
In this role, you will support the quality function by translating regulatory requirements into practical business needs and driving compliance across functions. You will contribute to quality and regulatory projects and help strengthen the local quality management system. The position offers exposure to audits, CAPA, and continuous improvement within a global medical device context. You will work with cross-functional teams to deliver compliant, efficient processes that support patient safety and care.
Arbeidsvoorwaarden / Benefits
- competitive salary
- local profit-sharing plan with target 10% bonus
- various benefits including monthly social gatherings and active employee association
- 40 days of paid time off per year
Verantwoordelijkheden
- Contribute to projects and value streams to ensure compliance with quality and regulatory requirements
- Prepare monthly quality metrics and analyze data to identify improvement opportunities
- Represent the organization in quality and operational processes such as CAPA, order fulfilment, and manufacturing
- Provide technical quality support across Quality and other functions to achieve business outcomes
- Participate in external audits by regulatory authorities and support internal audit plans
- Prepare audit plans, conduct audits and produce clear audit reports
- Issue non-conformities and support timely closure of corrective actions
- Support changes to processes and procedures, including review and approval of controlled documents
- Promote professional integrity, continuous improvement and Elekta values
Belangrijkste vereisten
- Bachelor in Engineering or related field; or formal engineering apprenticeship with relevant experience
- Experience in Quality, Regulatory Affairs or Engineering, preferably in a medical device environment
- Training in ISO 13485, ISO 14971, ISO 14001, applicable IEC standards, MDD, MDR and US FDA QSRs
- Ability to translate regulatory requirements into clear business requirements
- Structured problem-solving approach and familiarity with quality tools
- Strong written and verbal communication; ability to collaborate across functions
- Ability to work independently, manage priorities and meet tight timelines
- Fluency in English; additional languages may apply depending on location
- Quality-related professional certification is preferred
- Experience with Lean, Six Sigma, DOE or statistical methods is an advantage
- Willingness to travel when required
- Strong communication skills
- Cross-functional collaboration
- Independent and proactive work style
- ISO 13485, ISO 14971, ISO 14001
- IEC standards; MDD, MDR; US FDA quality system requirements
- CAPA, audits, and audit reporting
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