The Quality Engineer will be working with the process development and manufacturing teams to support the quality system efforts to assure that system requirements for process development and manufacturing are in conformance to the Entellus Quality Management System requirements.
Duties & Responsibilities:
- Provides quality engineering support to manufacturing. Where appropriate, dispositions nonconforming product.
- Provides trending for manufacturing scrap and nonconforming product.
- Approves receiving inspection paperwork. Where appropriate, dispositions nonconforming product.
- Maintains contact with vendors, and provides feedback to suppliers regarding performance and compliance to specifications.
- Independently designs experiments, develops protocols, performs process validations and data analysis, draws conclusions and communicates results.
- Represents the QA Department for process and/or design changes from verification to product implementation in manufacturing.
- Documents corrective and preventive action requirements, determines the root cause, determines the corrective action required, and monitors for effectiveness.
The successful candidate should possess:
- BS degree
- Minimum 4 years of experience in quality engineering with manufacturing support in the medical device industry.
- Must have strong knowledge of medical device GMPs and ISO standards applicable to the FDA and international regulatory agencies.
- Must have strong knowledge of manufacturing process controls.
- Superior time management, ability to work on several projects simultaneously and excellent communication skills required.
Entellus Medical delivers innovative, high quality minimally invasive therapeutic solutions to healthcare providers and their patients who...