Quality Assurance Engineer II

3 weeks ago

Acton, United States Katalyst Healthcares and Life Sciences Full time

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. Requirements: 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.

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