Senior Quality Systems Specialist
Stryker(2 months ago)
About this role
Senior Quality Systems Specialist based in Belfast responsible for leading quality system improvement and harmonization efforts to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other global medical device regulations. The role focuses on evaluating and improving processes, documentation, and controls to address opportunities identified through assessments and audits while partnering with cross-functional teams.
Required Skills
- Quality Systems
- CAPA
- Audits
- Design Controls
- Document Control
- Technical Writing
- Project Management
- Stakeholder Management
- Regulatory Compliance
- Risk Management
+4 more
Qualifications
- Level 6 Qualification
- Science, Engineering, or Business Degree Preferred
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