Quality Assurance Engineer- Level II

Responsibilities: The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles. Position Responsibilities: Drive continuous improvement actions focused on product quality. Works with Engineering and Manufacturing to develop acceptance criteria for production processes. Works with Service and the Complaint Handling Unit to investigate product problems, perform root cause analysis and identify possible corrective actions. nalyzes production quality data to identify trends or issues which require action or CAPA activity. ssists in creating and implementing procedures in the quality management system. ssists in the review and disposition of nonconforming materials. Assists in the creation and validation of manufacturing processes. Conducts internal audits of production processes and report results. Reviews manufacturing process and part deviations. Creates quality alerts when acceptance activities need to be adjusted. Supports external regulator or customer audits Provides response to inquiries related to quality assurance arising from tenders or other sales efforts. Performs other duties as requested. Requirements: Bachelor of Science degree in Engineering or related field. 3+ years relevant work experience. Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971). Experience with manufacturing/quality methodologies such as QFD, six-sigma, lean, etc. Understanding of statistical analysis techniques and tools. Experience with formal quality systems such as ISO 13485 or ISO 9001 and or CFR 210 & 211. SQ or related quality certification is preferred. Work experience in a FDA regulated environment is preferred. Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.) Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc. Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems. Excellent verbal and written communication skills using the English language. Able to coordinate multiple activities and actions of persons contributing to assigned tasks. Detail oriented with good organizational and record keeping skills. bility to work independently and as part of a team. Proactive and timely in execution of assigned tasks. ble to be flexible and adaptable when needs and priorities change Physical demands and work environment: