What are the responsibilities and job description for the Quality Assurance Engineer I-Medical device position at Sriven Systems Inc.?
Quality Assurance Engineer I - medical device
Location: Skaneateles, NY
Duration: 5-Month Contract
Experience: Entry Level (0 2 Years)
Job Overview
Baxter is looking for a Quality Assurance Engineer I to support manufacturing quality and quality systems. This role works closely with Engineering and Manufacturing teams to improve product quality, support process validation, investigate quality issues, and maintain compliance with regulatory standards.
Responsibilities
- Support Quality Assurance activities throughout manufacturing.
- Analyze production quality data and assist with CAPA.
- Review non-conforming materials and manufacturing deviations.
- Support process validation and Quality Management System documentation.
- Participate in continuous improvement initiatives.
- Assist with internal and external audits.
- Collaborate with cross-functional teams to ensure product quality.
Required Skills
- Bachelor's degree in Engineering or related field.
- 0 2 years of Quality or Manufacturing experience.
- Knowledge of CAPA and Quality Systems.
- ISO 13485 or ISO 9001 knowledge.
- Statistical analysis and Lean/Six Sigma concepts.
- Good communication and documentation skills.
- Proficiency in Microsoft Office.
Preferred Skills
- Medical Device or regulated manufacturing experience.
- GMP/FDA knowledge.
- Process Validation.
- Root Cause Analysis.
- Audit support experience.
Salary : $20 - $25