Job Summary
The Quality Engineer is responsible for overseeing Quality Design and Development initiatives across the entire product lifecycle. This role includes managing risk assessments and ensuring thorough process validation. The engineer will work closely with engineering teams to guarantee adherence to quality regulations and will assist in audits conducted by both customers and regulatory bodies.
Responsibilities
- Lead Quality Design and Development efforts throughout the product lifecycle.
- Conduct risk management activities and ensure effective process validation.
- Collaborate with engineering teams to maintain compliance with quality standards.
- Support customer and regulatory agency audits.
Qualifications
- A minimum of a four-year degree in engineering or a related quality field.
- 2-5 years of experience in a regulated manufacturing setting.
- Strong understanding of medical device standards, including ISO 13485 and 21CFR 820.
- Excellent communication skills and the ability to work effectively with diverse teams.
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.
