Job Title: Quality Assurance Specialist
Location: Pompano Beach, FL
Reports to: President/Vice President of Quality Assurance and Regulatory Affairs
Position Type: Full-Time
The Quality Assurance Specialist will develop, modify, apply, and maintain protocols for processing materials into partially finished or finished materials. Devises methods and procedures for inspecting, testing, and evaluating products and production equipment. Ensures that documentation and labeling meet acceptance criteria and are in compliance with requirements.
All employees have the responsibility to follow documented procedures, identify non-conforming products and identify and implement corrective actions. All employees are responsible for ensuring compliance of the Stimwave Quality Management System, ISO 13485, FDA QSR, AIMDD as well as international and national regulations/directives, as applicable.
- Experience with inspection equipment and documentation (e.g. calipers, pin gages, scales, sampling plans, inspection forms and records).
- Manage inventory control and maintain accurate tracking, counts, build orders.
- Management of nonconforming goods and trend assessment.
- Assist in tasks related to quality assurance such as internal audits, data analysis, and traceability.
- Work with Manufacturing to define quality inspection points.
EDUCATION REQUIREMENTS & PREVIOUS EXPERIENCE
- Bachelors degree or 4 years experience in the field.
- Demonstrated working knowledge of 21 CFR 820, ISO 13485, and cGMP.