Job Summary
The Quality Assurance Specialist is responsible for overseeing quality-related processes, ensuring that all operations align with FDA regulations and ISO 13485 standards. This role entails conducting inspections of both raw materials and finished products, while also providing support to cross-functional teams across manufacturing and distribution sectors.
Responsibilities
- Manage quality assurance processes, including Corrective and Preventive Actions (CAPAs), audits, and document management.
- Conduct inspections of raw materials and final products to ensure compliance with quality standards.
- Collaborate with various teams involved in manufacturing and distribution to promote quality in operations.
Qualifications
- A minimum of 2 years of relevant experience in the field, accompanied by a bachelor’s degree; or 5 years of experience if no degree is held.
- Experience in the medical device or pharmaceutical industry is highly preferred.
- Excellent proficiency in English is required.
- Strong interpersonal skills with an ability to effectively work in a cross-functional team environment.
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.
