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QMS and Document control Specialist
3 months ago
Your role:
- Define,maintain and enrich QMS process in alignment with business.
- Provide QMS training and process consulting to project teams.
- Change management and control of documents.
- Training assignments and tracking for compliance
- Facilitate ISO audits and FDA inspections.
- Evaluate process effectiveness.
- Define and manage software development KPI.
- Work with cross functional teams and functional leads.
You're the right fit if: (4 x bullets max)
- Minimum 8+ years of similar work experience in regulated industry
- Experience in management of QMS, Change management ,document control and audit management.
- Experience working with cross functional and project teams.
- Good Implementation knowledge of ISO 13485, IEC 62034, ISO 14971, 21 CFR Part 820, EU MDR
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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.