- Bachelor’s Degree in Mechanical, Electrical, Industrial, Reliability Engineering or related field.
- Minimum 10+ years’ experience in quality assurance field in a regulated environment
• Minimum 6+ years’ experience in medical device industry • Quality Certification preferred (e.g., CQE)
- Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971)
- Results orientation with strong written and oral communications skills to lead cross-functional teams
. • Ability to effectively lead and influence cross functional teams.
- Strong problem identification and problem solving abilities
