About The Role

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We don’t just build technology. We build hope for everyone dealing with Cancer.

Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com .

Description

Supports the Quality Assurance team with day-to-day activities, including preparation for external audits, and works closely with colleagues across the same and other functional groups

Responsibilities

ISO 13485 surveillance audit preparation

o Prepare audit-related lists, including NONCs, CONCs, and CAPAs.
o Liaise with other departments to obtain required documents and records.
o Work with Manufacturing to ensure production areas are ready for inspection.
o Review documents and records to identify Good Documentation Practice (GDP) gaps.
o Work with subject matter experts to develop hot-topic timelines.
o Follow up outstanding actions requiring closure before the audit.
Prepare supporting documentation for the Stage 2 ISO 9001 and ISO/IEC 27001 audit.
Provide administrative support for ongoing document update projects.
Support the internal audit programme by scheduling meetings and sharing initial audit plan details with auditees.
Provide administrative support that enables the QA team to focus on core activities.
Assist with preparing quality metrics.
Promote quality across cross-functional forums.
Contribute to process improvements, efficiency initiatives, and team projects.
Promote and uphold Elekta’s values.

Authorities

Review documents and records for compliance with Good Documentation Practice (GDP).
Distribute documentation to support QA activities.
Identify improvement opportunities and escalate them through the appropriate reporting line.
Prepare reports, spreadsheets, and documentation to support data analysis.
Relevant Knowledge, skills and competencies
Working knowledge of key Microsoft applications, including Word, Excel, Teams, and PowerPoint.
Strong attention to detail when reviewing documents and records.
Effective team player with a positive attitude towards change and supporting Elekta’s business goals.
Confident, open, and approachable.
Strong written and verbal communication skills, with the ability to support collaboration.
Able to work efficiently, independently, and under tight timelines.