What are the responsibilities and job description for the Quality Engineer position at SARACA?
Job title: Quality Engineer III
Location: Southington, CT (Onsite)
Essential Duties & Responsibilities:
- Lead non-conformance containment, remedial actions, and root cause investigations—track trends related to UAI, rework, and scrap.
- Process and efficiently investigate medical device customer feedback (complaints) in a fast-paced environment.
- Apply engineering principles and methods to resolve moderately complex engineering issues.
- Write clear, timely reports and collaborate effectively in team environments with shifting priorities.
- Maintain effective communication with internal and external stakeholders, including customers, product engineering, and regulatory personnel.
- Create and review essential quality documentation, such as Control Plans, PFMEAs, 8Ds, and PPAPs.
- Conduct internal and compliance audits to improve the Quality System.
- Participate in corrective action teams (8D or 5-Why) to address quality defects.
- Stay updated on quality and regulatory topics and improve inspection effectiveness.
Knowledge, Skills & Qualifications
- Strong understanding of best practices and engineering disciplines.
- Ability to make decisions that impact project success.
- Experience with Class III device design and development (e.g., critical care patient monitor catheters) is a plus.
