Quality Engineer - Nonconforming Materials System

August 28

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PROCEPT BioRobotics

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Aquablation therapy - the BPH treatment of choice for all prostates.

Surgical Robotics

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Description

• NCMR QE will help the NCMR process owner with maintaining the NCMR process in Propel, trend NCMR data, manage the overall NC workflow process, and maintain NCMR metrics data integrity. • Conduct weekly NCMR review meeting to review status of open NCMRs. • Provide NCMR trend analysis and reported during periodic management Review meetings. • As NCMR Propel Coordinator this role is responsible for supporting the NC process workflow and re-assigning NCMR approvers as required. • Assist NCMR approvers by ensuring overall information documented on the NC including supporting documents are accurate, relevant, and complete. • Support and back up to MRB Coordinator managing, labeling, and maintaining the quarantined materials as they move in and out of the MRB Cage, and performing any enterprise resource planning (ERP) transactions.

Requirements

• Bachelor of Science in Engineering or combination of relevant education and experience. • 3 – 6 years relevant experience in medical device manufacturing. • Experience in medical device manufacturing and with strong working knowledge of cGMPs. • Manufacturing or Quality Engineering experience. • Experience with Nonconforming material software tools. • Experience with development and authoring procedures (SOPs, Work Instructions). • Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred). • Demonstrated knowledge of Project Management principles. • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485. • Strong organizational skills, detail oriented. Exceptional oral and written communication skills. • Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.) • Ability to work to a deadline and to handle multiple tasks simultaneously. • Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.