Director of Quality

**Director of Quality (QMR, Site Quality Leader Medical Device Manufacturing)** **-** ** ****Description**Currently we seek a Site Quality Leader and Director of Quality for the Tijuana manufacturing facility. S/he is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within that facility. This role provides leadership to all functions within the Tijuana QA Organization to achieve quality goals as well as growth objectives.The Director of Quality is responsible for achieving Quality scorecard metrics and operational targets, corrective actions, and the implementation and maintenance of an effective and compliant Quality Management System. The Director must possess proficient interpersonal and communication skills to interact cross functionally and must be able to communicate effectively with senior management, Legal, external resources, and suppliers.The overarching goals of the role are to assess, develop, and direct the company quality assurance policies, procedures, and programs; to ensure compliance with these activities by interacting with suppliers, customers, and other departments within the company; to ensure product/process compliance through control documentation, auditing and pilot/prototype production; and to ensure ISO 13485 standards, FDA QSR, MDSAP and lead the audit process.REPORTING RELATIONSHIPS:The Director of Quality for the Tijuana manufacturing facility reports directly to the VP Quality Assurance Small Capital. As the Site Quality Representative, the Director leads a complete team of 31 of which 15 are quality professionals and 16 inspectors.LOCATION:ESSENTIAL DUTIES AND RESPONSIBILITIES:- Oversees the development, implementation, and maintenance of quality procedures regarding inspection/test of purchased materials, manufactured assemblies, and finish products.- Ensures the compliance with all applicable customer requirements (e.g., Quality System Regulation, ISO:13485, MDSAP).- This includes auditing through product testing to ensure compliance to the seated specifications.- Develops and approves quality policies and objectives for the company. Conducts periodic reviews to assure they're appropriate and effective.- Develops, implements and directs action procedures for the company and follow-up to assure their effectiveness. Assures revision to non-conforming material and determines disposition, and corrective action.- Contributes technical and managerial skills to new product development. This includes managing prototype/pilot manufacturing activities from quality perspective.- Participates in company strategic planning.- Prepares, administers, and controls the Quality Assurance annual budget.- Ensures that current and newly developing manufacturing/engineering technology are implemented consistent with Quality standards.- Defines, communicates, and measures performance of all Quality Assurance personnel. This includes assessment of job skills and training, administering performance appraisals, and oversees career development.- Interfaces with Marketing, Customer Service, Purchasing, Manufacturing Engineering, R&D, Production, and Suppliers on quality related issues affecting products or service.- Responsible to manage the CAPA system.- Is member of the CAPA Review Board, acting as responsible for the oversight of the organization’s CAPA system, and ensuring that it is established and maintained.**Qualifications**- Bachelor’s degree in a related medical, science or regulatory discipline required. Engineering degree strongly preferred- 8+ years in the medical device industry or related GMP environment or equivalent.- 3+ years of experience leading direct reports.- Demonstrated strong proficiency with Microsoft systems (Excel, PowerPoint, Word, and Project).- Thorough knowledge and understanding of medical device regulations and standards, including but not limited to QSR, CMDR, Medical Device Directive and the EU Medical Device Regulation- Experience in the ISO Quality System and other applicable industry requirements is required.- Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.- Exceptionally strong leadership and influencing skills.- Must have the ability to make effective presentations to all levels of the organization.- The proven ability to prioritize and manage multiple projects and meet deadlines is required.- Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.- Experience building a high performance team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.- Strong appreciation of the impact of regulatory