Sr. Quality Engineer

Job Description The Sr. Quality Engineer will ensure a high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas. MUST-HAVES Bachelor's degree or higher (engineering/science) 3+ years quality engineering with 1+ year Med device industry Know GD&T, Solidworks (read drawings), root cause analysis and CAPA Can move NC from beginning to end, can come up with solutions Experience with Critical to Quality Attributes (CTQ) - tolerances on drawings NICE-TO-HAVES Gage R&R, CMM (Coordinate Measurement Machine) Understanding of measurement methods Responsibilities Work closely with internal departments (Operations, Advanced Operations, R&D, and Distribution) to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-proofing, etc.). Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, regulatory actions, etc. Lead and/or support CAPA investigations and related corrective and preventive actions. Lead continuous improvement activities such as Quality Circles, Process Capability. Support Lean environment and re-work/scrap reduction. Participate in the development and improvement of manufacturing, distribution and/or other processes for existing and new products. Participate on project teams with internal departments to support product and/or process design and development activities. Develop, review and improve inspection plans, routers and product drawings. Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Interface with suppliers for new processes, quality issues and process improvements for assigned projects. Support product transfers to other plants/facilities. Lead or participate in implementation of Process Management activities (pFMEA and control plans) within assigned client groups. Review/approve product and/or process change control documentation and specifications. Participate in continuous (breakthrough) improvement activity and process re-engineering projects. More Information Relocation allowance up to $10,000 Salary range: $60,000 – $75,000 Performance bonus: $0 – $5,000 #J-18808-Ljbffr