Medical Device Risk Manager
Vor 7 Tagen
Qualifications
- Bachelor's degree in engineering (Mechanical, Systems, Chemical or Electrical) or Science (Biology, Chemistry).
- 8 years of experience working within a Medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
- Strong analytical skills and a working knowledge of problem-solving methodologies.
- Working knowledge of DFSS techniques.
- 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development.
- Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology.
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making.
- Demonstrates excellent organizational, verbal and written communication skills.
- Proficient with the MS Office Suite, and statistical software.
- Must be able to work independently with minimal supervision.
- Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives.
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