NPI Quality Engineer

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Job description

Job Description: Support quality systems by collecting and providing information to internal and external customers and perform tasks such as generating engineering change orders and ensuring quality system paperwork is up-to-date and meets GDP compliance. Support the quality team during audits and visits (i.e., customer, regulatory, registrar, internal). Manage customized SAP activities such as generating and maintaining the corrective action, doc control, calibration and RMA/complaint systems. Actively participate in continual improvement, corrective actions, and customer satisfaction. Coordinate and facilitate document control activities related to procedures, work instructions form control, and quality and EMS records. Support collecting, compiling, and formatting process indicators into presentable formats for reporting and management reviews. Set-up suitable measurement systems to monitor and measure the quality of the product and process. Lead and facilitate risk management techniques during the early phases of the project. Participate on any root cause analysis on any nonconformances found during the manufacturing process. MINIMUM REQUIREMENTS: Bachelors degree in Industrial Engineering, Mechanical Engineering, or related engineering or science field and two (2) years of experience in a quality technician role. Must have two (2) years of experience in each of the following: Utilizing Statistical Data Analysis for validating manufacturing processes and making data-based decisions using process capability studies, GageR&R, and Hypothesis testing; and Conducting Root Cause Investigation for any failures identified during validation or sustaining manufacturing using Fishbone, 5 Whys, QNs, and Process flow diagrams. Must have one (1) year of experience in each of the following: Applying 13485 Quality System and FDA Part 820 requirements; Utilizing Risk Management tools such as PFMEA and Control Plans; and Completing statistical studies using Minitab. Telecommuting permitted up to 2 days/week. To apply, send resume to Please include Job Number 164742 in the subject line.

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