Quality Manager in Sterling

Essential Duties and Responsibilities

• Maintain a robust Quality Management System (QMS) that meets ISO 9001:2015 and ISO 13485 requirements.
• Design systems by which production quality can be checked in an ongoing process.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Work with the production team to implement any new testing criteria or assembly methods they may have developed.
• Establish quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers while ensuring consistent interpretation throughout the Quality and Manufacturing workforce.
• Establish raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, devising testing methods and procedures.
• Ensures adherence to in-process product inspection standards by studying manufacturing methods, devising testing methods and procedures.
• Monitor, test and inspect products to make sure they meet specified standards, as applicable.
• Verify product dimensions, texture and strength and locate imperfections as applicable.
• Test the proper fit of components, when applicable.
• Use tools such as micrometers, calipers, gauges, vision system etc.
• Completes quality assurance operational requirements by scheduling and assigning employees, following up on work results.
• Implement and maintain Customer Complaint and Medical Device Reporting System. Coordinate corrective action system for external and internal problem resolution.
• Promotes and maintains awareness of the Quality Management System through the company and especially quality assurance staff by training employees.
• Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.
• Mange the internal audit, CAPA and Management Review efforts.
• Manage supplier quality.
• In close coordination with the project team, utilize and implement APQP, PPAP and IQ/OQ/PQ, as required, with new and transferred projects.
• Lead communication efforts, as appropriate, regarding project status and other quality-related customer information.
• Other assignment(s)/duties as assigned.