Design Controls Engineer Consultant
Location: Bothell, WA
Duration: 9 months
Experience: Minimum 8 years professional experience in the applicable role.
Education: Bachelor's /Master's degree in Engineering. Demonstrated capability and experience in role. Quality Engineering position that covers a broad range of R&D activities crossing things such as Sample Size Statistics, confidence and Tolerance Intervals, Risk Assessment, Chain of Custody, Supplier Qualifications, IQ/OQ/PQ, tooling, CpK, test methods, and a long list of interests in SOPs, Work Instructions, Checklists and more. Actively participate and drive improvement activities as required. Assure deployment of appropriate validation planning and robust design transfer, Apply subject matter expertise in Process Excellence, 6 Sigma, and CQE tools where appropriate, Review, evaluate and endorse investigation documentation for incidents and deviations, Provide QA support to manufacturing departments, Evaluate and update existing SOP's for cGMP compliance, Facilitate, coordinate and champion investigations, Perform and participate in investigations, Participate in and perform internal audits, Communicate and determine disposition for quality issues within the facility. Participate in the Annual Product Review report process, Develop and maintain metrics / trending for incidents, deviations and CAPA items, assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve deviations and non-conformances, experience may include Quality and Regulatory aspect of manufacturing, Validation and Design Control, Metrics, Data Analysis and Statistical Techniques, Investigations and Root Cause Analysis, CAPA and NC and Lean Six Sigma tools.
Employment Type: Contract