Job Summary
The Quality Engineer is tasked with overseeing Quality Design and Development initiatives throughout the entire lifecycle of products. This role includes crucial responsibilities such as risk management and process validation, ensuring that all quality-related aspects align with industry regulations.
Responsibilities
- Manage Quality Design and Development activities throughout the product lifecycle.
- Conduct risk management and process validation.
- Support manufacturing qualifications and compliance with quality management systems.
- Perform audits to ensure adherence to regulatory standards.
- Ensure overall compliance with relevant quality regulations and practices.
Qualifications
- A minimum of 2 to 5 years of experience in a regulated manufacturing setting, ideally within the medical device industry.
- A four-year degree or equivalent relevant industry experience.
- Familiarity with ISO 13485, 21CFR 820, and statistical quality methodologies.
STEMHUNTER 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.
