Job Details

Responsibilities Perform and/or monitor various quality tests on product qualification, first articles acceptance, product inspections and analysis, and create/maintain/proofread their records, inspection sheets, spec sheets, drawings and procedures as needed. Participate in IQ/OQ/PQ activities including the creation of protocols and reports. Assist manufacturing and engineering with Qualification/Validation activities for production/manufacturing processes Investigate CAPA to identify product, process and performance and/or non-conformance issues, which require corrective or preventive action. Proactively identify improvements in product design and testing to prevent performance problems, customer dissatisfaction, test non-conformances and regulatory compliance problems. Perform failure investigations; analyze corrective action trends/data and recommend remedial action. Perform technical evaluation of process yields and quality control to determine process capability, measurement to obtain yield improvement, enhance consistency of production and implement statistical process control (SPC) as a management tool. Assist in maintaining compliance with RoHS and REACH requirements Participate in supplier performance evaluation and audits. Promote quality policies and procedures to comply with requirements of FDA Regulations and ISO Standards. Requirements Minimum 3-5 years of quality engineering experience, preferably within the medical device industry BS Degree in Engineering or Physical Science required Working knowledge of QSR/ISO requirements strongly preferred. Working knowledge of quality assurance principles and practices. Quality certification (CQE, CQA) is desirable. Excellent communication and writing skills to support effective correspondence with internal as well as external customers/suppliers. Knowledge of inspection methods in the design and fabrication of medical devices Ability to read and interpret blueprint drawings and specifications. Knowledge of statistics, statistical process control, process capability, data analysis and chart interpretation (histograms, trend charts, etc.) Ability to work well in a team environment. Proficient in the use of MS Office software.