What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Envista?
Job Summary
This Quality Engineer will lead the development and implementation of quality strategies for sustaining and new products. They will work closely with cross-functional teams to ensure the quality of our medical devices meets regulatory requirements.
Responsibilities include:
- Developing and implementing quality strategies for sustaining and new products.
- Collaborating with cross-functional teams to develop and implement corrective and preventive actions (CAPAs) in response to reported complaints.
- Overseeing post-market data and driving KPIs to targets.
Required qualifications include a Bachelor's degree in a relevant field, 5 years of experience in the medical device industry, and 3 years of direct supervisory and decision-making experience. Knowledge of FDA regulations, ISO 13485 MDSAP, EU MDR is also required.
