Job Summary
The Quality & Manufacturing Engineer is responsible for orchestrating the establishment of an FDA-compliant Quality System while overseeing supply chain processes, including the integration of new suppliers. This role requires collaboration with both internal teams and external partners to formulate Standard Operating Procedures (SOPs) and maintain continuous compliance with regulatory standards.
Responsibilities
- Lead the development and implementation of an FDA-compliant Quality System.
- Oversee supply chain functions, focusing on supplier onboarding and integration.
- Work together with internal and external stakeholders to create and update SOPs.
- Ensure continuous compliance with industry regulations.
Qualifications
- Bachelor’s degree in engineering or a related field.
- Minimum of five years’ experience with quality systems in the medical device sector.
- Strong background in supply chain management, particularly for electronic medical devices.
- Excellent project management abilities.
CAIRA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
