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Job #02652

About our client Our client is a rapidly growing company headquartered in Massachusetts that is focused on the quality manufacturing of plastic consumables for research and medical diagnostic laboratories. The company's strengths are design and production innovation, flexibility, and the ability to listen to their customer’s needs. Position Location Quality Assurance Manager Cambridge, MA Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor, maintain and improve Quality Management System based on cGMPs and ISO requirements 2) Ensure that all daily functions of the Quality Management System are implemented at all levels 3) Work as a management representative 4) Ensure that all company personnel are trained in relation to Quality Management System requirements 5) Monitor and maintain Sterility Program, including sterility validations, specifications and approvals 6) Ensure that all quality and regulatory requirements are implemented for all products and processes, including writing and performing product and process validations 7) Direct and supervise the work of the employees of the Quality Department 8) Control all documentation, including, but not limited to corporate quality policy, quality manual, SOPs and associated forms 9) Handle all product specifications and drawings/prints 10) Write all product and process-related documentation (manufacturing, engineering, warehouse, shipping, receiving, packaging, etc.) 11) Develop, implement, perform and maintain tool and test equipment calibration program 12) Chair the bi-weekly Material Review Board with emphasis on root cause analysis and corrective action 13) Develop and implement standards and procedures for inspecting, testing and evaluating product assurance and reliability 14) Apply statistical tools to measure and trend quality performance meeting quality standards 15) Perform supplier/vendor audits as per the established requirements of the company and cGMP 16) Assist in facility development and maintenance 17) Implement and maintain the Customer Complaint and Medical Device Reporting System 18) Coordinate the Corrective Action System for external and internal problem resolution 19) Assist in developing new products and packaging 20) Perform internal audits per cGMP and ISO requirements 21) Assist in any and all other company functions (as needed) 22) Act as a Safety Director and perform other duties (as assigned) 23) Coordinate and champion a continuous quality improvement program Requirements 1) BA/BS degree 2) 3 – 5 years of quality assurance experience 3) Supervisory experience 4) Knowledge of cGMP