Supplier Quality Engineer, Medical Device Manufacturing

Supplier QE
Medical Instrumentation developer and manufacturer has immediate
need for Supplier Quality Engineers.

·Maintain and assure compliance with appropriate regulations/standards relative to medical device design, engineering, manufacturing and distribution (i.E. FDA QSR, ISO 13485, Medical Device Directives, UL, IEC, etc.).
· Establish and/or improve product/process quality and through Focused Factory Team base problem solving efforts RCTQ tools.
·Participate in the MRB activities during process development of product and productions. Evaluate nonconformance reports as required; coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of corrective actions.
· Coordinate supplier corrective action activities with Purchasing and other departments as necessary for supplier quality issues.
·Ensure proper validation of IQ, OQ and PQ of equipment, documentation, processes through review of validation plans and subsequent audit (s) of those activities at the supplier’s location.
·Provide technical guidance for supplier improvement activities, review and evaluate ECR / ECO for accuracy, effectiveness and compliance and provide support to the component CCB process. Perform audits on supplier manufacturing processes to assure compliance at subassembly and system levels.
·Provide design input (s) related to the quality during the design and development phase.
·Perform appropriate analyses and evaluations, as needed, to make recommended changes.
REQUIREMENTS
Requires B.S. Electronics Engineering and 3 years of industry experience as a
quality engineer or A.S. Degree in electronics and 7 years of industry
experience as a quality engineer or 10 years of medical device industry
experience as a quality engineer. Six Sigma Green or Black Belt preferred.