Quality Management System Expert
- Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
- Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.
- Analyze existing processes and ensure integration and consistency across shared, linked, and cross-functionally dependent processes.
- Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR and other applicable regulations.
- Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
- Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
- Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
- Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.
- Degree in Engineering, Scientific.
- 7+ years of quality-related system experience in a medical device company developing medical devices.
- Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to detail.
- Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR).
- Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills.
- Advanced problem-solving, organizational, analytical and critical thinking skills.
- Certified lead auditor.
- Electronic QMS experience is preferred.
- Excellent command of English language.
Great opportunity to join an amazing team and work on challenging projects.
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