Quality Assurance Specialist Westbrook, ME Our client is a growing medical device manufacturing company headquartered right here inMaine. They have been in business for more than 30 years and are one ofMaine's fastest growing businesses. SUMMARY: Ensure product quality is maintained at standards set forth by the quality system and mandated by regulatory agencies. Focus areas will include evaluation of product received, final review and release of product, Tool calibration system maintenance, Supplier assessment, approval and approved supplier list coordination, Act as the Nonconformance/Deviation coordinator. This person will report to the Director of Quality & Regulatory Affairs. ESSENTIAL JOB FUNCTIONS: Perform inspections on product at receiving inspection, in process and final inspection Perform DHR final review and release for all devices Maintain quality records as appropriate to this position and the quality department Prepare data of all quality objectives assigned to the quality department Make recommendations for improvements based on data results Ensure compliance of the document control system Work with teams to determine root cause of corrective actions, propose solutions and confirm effectiveness of the correction Manage calibration program - Implement gage track software for tracking calibrated equipment, tools and fixtures Manage nonconforming material process - including preparation for MRB meetings, Maintaining the NC/Deviation log, Maintaining order in the quarantine cage QUALIFICATIONS: Knowledge of GMP, ISO 13485 and FDA 820 requirements Minimum 1 year experience in a regulated industry Ability to interpret engineering drawings and utilize measurement equipment to determine if product meets the specifications Meticulous attention to detail Excellent organization, documentation and communication skills Computer proficient, above average usage with excel: pivot tables, data review and presentation techniques To Apply - Please send a Word version of your resume to email@example.com. Once reviewed, our team will contact you regarding the next step. If your resume is not a strong match for this position we will build a profile for you and contact you regarding future openings that are a better match for your skills and experience. All the best, The Adecco Team
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