What are the responsibilities and job description for the Quality Assurance Engineer position at Entegee?
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.
- 2 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
- Problem solver, capable of facilitating the problem-solving process
- Adaptable and effective collaborator in a team environment and in self-directed work
- Strong communication skills (verbal & written)
- Ability to work in a highly matrixed and geographically diverse business environment
- Demonstrated use of Quality tools/methodologies
- Preferred qualifications:Previous Software or Capital equipment Design Assurance experience is a plus
- Medical device or other regulated industry experience
- Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
- Experience with 60601, software and cybersecurity
- Experience working in an Agile environment