Posted: Thursday, May 11, 2017 4:14 AM
Provide support for Surgical development projects from project inception through successful Technology Transfer/Scale:Up at the manufacturing facility. Additionally the role will support marketed product changes and updates (MOB). The role includes working with multidisciplinary teams to insure medical device development activities are planned and executed in compliance with Design Control Requirements and Bausch + Lomb/Valeant procedures. Provide Quality Assurance support to sites as needed.Represent Design Quality on multi:disciplinary new product development and MOB teams. Duties will include: Ensure project plans adequately address design, validation and Quality departmental requirements and standards. Work with functional departments to ensure tasks are executed compliantly. Management and documentation of Design Control activities through post launch review (approximately 1 year post launch).Documentation of Risk Management requirements per ISO 14971.Review/approve GMP documents (e.g. production records, analytical method validation, engineering/validation protocols/reports, specification updates (DCOA?s, QCRA?s)Facilitate GMP production readiness and launch activities, including technology transfer and validation.Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.Support post launch design changes and product updates as required. BachelorA?s Degree (BS) in engineering or scientific discipline (Chemistry, Biology, Microbiology). Experience: Three years experience in Medical Device and/or Pharmaceutical Industry in Quality, R and D, Engineering or Laboratory environment. Specific experience desired is as follows:Three years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices.One year utilizing corrective and preventive action (CAPA) system that is in compliance with US federal and international regulatory standards relating to medical devices.One year Complaint management, complaint review and corrective action.One year Utilization of root cause analysis tools, including fault tree analysis, 5 Whys, Is/Is Not,One year risk analysis experience.
• Location: Rochester
• Post ID: 25164308 rochester