Quality Assurance Engineer Jobs in USA, NY, Skaneateles Falls | Rose International Job

Education Requirements

• Bachelor's degree in EngineeringRequired Skills for the Engineer
• Quality Complaint Investigation
• 1-3 years of Medical Device experience
• Investigational research skills
• Experience with any statistical software packages
• Knowledge and working application of FDA cGMP;

ANSI/ISO/ASQC

requirements

• Knowledge and working application of reading and understanding blueprints and technical drawings
• Demonstrated strong analytical problem solving
• Root Cause Investigations
• Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools
• Computer competency in Word, Excel, Power Point, Minitab, Access and databases
• Ability to multi-task and methodically manage projectsPreferred Skills
• Medical Device knowledge of 21CFR820 preferred
• Minitab statistical package
• Experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
• CMDASEngineer

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Quality Complaint Investigation Overview:

This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

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
• Analyze 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; Prepare and issue reports based on information analysis
• Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner
• Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products
• 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 or lead 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
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.

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