Job Title: Quality Specialist
Pay: $30.00 - $35.00/hour
Position Summary: Support the Quality Assurance team and Quality Management Representative with effectively managing the Total Quality Process, which requires a very strong focus on the overall Quality Process. Responsible for identifying key process and product performance and quality issues for our products, and then works cross-functionally to continuously improve each key quality parameter. Assure compliance with all FDA, GMP, ISO, OSHA and similar regulatory and quality requirements.
Essential Duties and Responsibilities:
- Performs general quality system support for product production. This includes coordinating site product release and other quality system support functions as needed. Assists manufacturing in completing deviation or non-conformance reports when product/process issues are identified.
- Supports customer complaint investigations with guidance from QA Manager.
- Performs day to day quality final product release. Checks product quality; looks for defects, signs off on lot specific manufacturing documentation.
- Facilitates CAPA (Corrective Action Preventive Action) initiation, tracking, and closure activities.
- Processes Product Design Transfer and Design Changes initiated by the company and associated tracking activities.
- Maintains Device Master Records (DMR) and supporting documentation.
- Maintains Device Master Records (DMR) and Supports Document Control processing and Training Impact Assessment activities.
- Fosters an environment of continuous quality management improvement.
- BS in Science preferred.
- Minimum of 2-4 years of Quality Assurance experience in Medical Device.
- Previous experience with CAPA.
- Experience with product release.
- Working with non-conformance reports.
- Experience supporting Quality Systems.