Quality Assurance Engineer II - Katalyst HealthCares and Life Sciences
Acton, MA 01720
About the Job
Responsibilities:
- Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined" problem code and cause codes for each complaint.
- nalyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues.
- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
- Conduct corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
- Support CAPA and maintenance activities for existing product lines.
- Recommend and/or support projects for improvements to the quality system as approved by management.
- Support material review board
- Develop dispositions for nonconforming material using engineering / risk-based rationale.
- Coordinate the quarantine of nonconforming material.
- Communicate with suppliers about material that does not meet specification.
- Provide quality support to various improvement projects
- Perform quality duties as assigned by Quality Manager
- To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.
- Knowledge and working application of reading and understanding blueprints and technical drawings.
- Demonstrated strong analytical problem solving (Root Cause Investigations).
- Computer competency in Word, Excel, Power Point
- bility to multi-task and methodically manage projects.
- Critical thinking
- ttention to detail
- Collaboration & Teamwork
- Dealing with Ambiguity
- Strong ability to balance multiple priorities
- Medical Device Experience with knowledge of 21CFR820 preferred / ISO 13485 / FDA cGMP
- Competency in SAP
- Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
- Bachelor of Science degree in Engineering
- 0-3 years of Medical Device experience
- ble to exert up to 10 pounds of force occasionally.
- ble to sit, stand, walk throughout the workday.
Source : Katalyst HealthCares and Life Sciences