Senior Quality Engineer

We are seeking a qualified individual to develop, implement, and maintain quality engineering methodologies, systems, and practices which meet Horizon Surgical Systems’s Quality and Regulatory requirements As a senior member of our team, you will provide quality engineering support in the design, development, and manufacturing of Horizon products to ensure that the products conform to established specifications and consistently meet or exceed the requirements of our customer and patients Works with Product Development and Operations teams to establish quality requirements at all phases of product/process development and manufacturing Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports Work with Product Development on the Risk Management Process and maintains the Risk Management File Responsible for the Design History File, device Master Record and its maintenance Responsible for setting up the receiving inspection area, perform materials inspection such as incoming, First Article Inspection, and final product release Responsible for documenting product discrepancies and follow up on NC implementation and closure Responsible for all supplier management activities including sourcing and qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing the Supplier Corrective Action Request (SCAR) program Responsible for CAPA management from CAPA generation to implementation of corrective action, verification of effectiveness, and closure Assists with internal audits. Assists with hosting external audits and drive all issues to closure if need be Responsible for product packaging/labeling and ensuring all materials are conforming with applicable regulations Other duties as assigned This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technologyEffective written and verbal communication and organizational skillsBS degree in Engineering, life sciences or related field – Advanced degree preferredApplies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulationsExperience with software and firmware V&V is strongly preferredExperience with design control is a mustBe able to coach others or teach the proper use of quality tools and problem solving techniquesExcellent people skills, team orientedExcellent problem-solving skills5 plus years experience as a Quality Engineer or in related field in the medical device Industry. ASQ CQE is a plus #J-18808-Ljbffr Horizon Surgical Systems