Senior Quality Assurance Engineer
4 weeks ago
We are seeking a skilled Senior Quality Assurance Engineer to join our team at Entegee, a leader in custom automation projects and robotic solutions. In this role, you will play a crucial part in ensuring the quality and compliance of our medical devices.
Salary RangeThe estimated annual salary for this position is $71,600 - $83,200, based on an hourly rate of $35-$40.
Job Responsibilities- Investigate complex product quality and compliance issues from the field, analyze results to determine root causes/probable causes.
- Perform hands-on device investigation using various test equipment to determine root cause.
- Assess events against risk documentation for clinical/compliance risks; escalate as necessary.
- Participate in escalation tasks such as Project Risk Assessments (PRA) and Corrective/Preventive Actions (CAPAs), SCARs based on investigation findings.
- Report key complaint metrics by device category; collaborate with manufacturing teams to resolve production/device related issues.
- Bachelor's degree in engineering with 0-2 years of related work experience.
- Experience with medical device complaint investigations, including CAPAs, NCRs, and Root-Cause Analysis.
- Proficiency with the Microsoft Office suite.
- Experience performing functional, physical, and visual testing of medical equipment in a laboratory setting.
- BASIC understanding of statistical techniques.
- Solid knowledge of engineering principles, theories, and concepts.
- Familiarity with Quality systems and adherence to their regulations.
Our company offers a comprehensive benefits package, including:
- Medical, dental, vision insurance.
- Term life insurance.
- Short-term disability insurance.
- Addition voluntary benefits.
- Commuter benefits.
- A 401K plan.
Entegee specializes in custom automation projects and is a major player in the world of controls and robotic solutions around the world. We pride ourselves on helping our associates grow and expand their resumes to become top-performing professionals.
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