Director of Quality

Director of Quality – Medical Devices

Buffalo Filter is a leading medical device company in the Buffalo area that designs, manufactures and markets products for the hospital, veterinarian, and physician healthcare arena. Our innovative products and technology have enabled us to grow at least 30% each year.  Directly responsible for leading and directing Quality Assurance to implement, improve and monitor all company quality systems to demonstrate compliance with ISO13485:2003 and FDA QSR requirements. Manages Document Control and all Quality Control functions to assure compliance with the corporate Quality Management System and appropriate standards.  Provides regulatory guidance to management, customers and staff as required.

Responsibilities: Lead the Quality Systems function and ensure facility compliance to the Quality Management System and all other external regulatory standards. Serve as facility Management Representative to ensure that the quality systems requirements are effectively established and maintained. Coordinate and lead management reviews at specified intervals. Report on performance of the quality system to Executive Management at regularly established intervals. Conduct due diligence internal and external audits. Create and manage all associated documentation relating to internal and supplier audits. Maintain the Technical Files, Declarations of Conformity (MDD, CE) and Design History Files to assure US and International compliance. Work with Engineering/Operations to review and approve all required documentation requirements including Engineering Change Notices (EC’s), Device Master Records (DMR’s), SOPs, labeling and instructions for use. Work collectively with Customer Service on customer complaints/issues. Create and manage complaint files, MDR's, Corrective and Preventive Actions. Perform SOP training as required. Manage on-site ISO and FDA audits.

·        Maintains Quality System Manual

·        Serves as principal contact for ISO registrar, FDA and customer audit groups

·        Creates, develops or coordinates all QMS standard operating procedures and forms

·        Develops and manages supplier quality management/audit programs

·        Supervise and manage Quality Assurance Engineer

Required Qualifications: BS, Quality Engineering or related 5+ yrs exp related to quality management in medical device industry Planning and execution responsibilities ensuring compliance to all domestic and international standards: ISO 13485, FDA QSR, cGMPs Seeking a strong leader with passion for their work and demonstrated ability to drive positive change efforts. Excellent leadership, communication and computer skills Must enjoy a hands-on role in fast-paced, dynamic environment. Ability to work both independently and within diverse cross-functional team environment