The Senior Director, Quality Make is responsible for directing and overseeing quality activities at the EES Independencia, the integration of NeuWave, Megadyne and Torax acquisitions into J&J Supply Chain, for overseeing manufacturing locations where ETHICON LLC and ETHICON Endo-Surgery LLC products are manufactured, and for overseeing the performance of external manufacturers of finished products bearing the EES LLC or ETHICON LLC name. These responsibilities include leading actions to reduce risk of non-conforming product, ensuring the suitability and effectiveness of the manufacturing location’s quality management system, implementing systems and controls to ensure high-quality reliable product supply, operational efficiency and consistency, and compliance with applicable regulatory requirements, as well as selecting, developing, and leading staff to perform quality functions consistent with strategic plans for ongoing implementation and improvement of the Quality System and processes. This position is located at the ETHICON LLC Headquarters in Guaynabo, PR, is a member of the ETHICON LLC Management Team, and reports to the Johnson & Johnson Medical Device Group VP Quality MAKE. This leader will work cooperatively with Johnson & Johnson leaders to implement programs to improve overall quality, improve operational efficiency, enhance organizational capability and diversity, and assure regulatory compliance. Essential Functions/ Duties and Responsibilities The Senior Director, Quality MAKE leads the Quality Operations at the sites in scope by ensuring the appropriate Quality Operation Leadership is available at all times, skills and competencies are consistent with present and future needs, verifying that Quality Systems are in place to maintain the required compliance level across all manufacturing sites, and driving Quality System execution while reducing risk of non-conforming product. Ensures sites assess QS effectively through internal audit and Management review and implements corrective/ preventive, improvement actions as appropriate. Ensures sites address customer feedback and complaints in appropriate and timely manner. Ensures that site’s implementation of Quality Systems and goals are integrated in a cost effective and productive manner. Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards. Establishes and monitors metrics for the measurement of Quality indicators and Quality costs to ensure effectiveness and value to the business. Developing & implementing annual budgets & organization plans. Designated as Management Representative for ETHICON LLC and ETHICON Endo-Surgery LLC, Guaynabo, PR. As a member of the LLC Management Team, this leader has ownership for the quality activities of the manufacturing plants supporting the LLC businesses including product risk assessments, field action oversight and the investigation of manufacturing-related complaints. In addition, this role is responsible for the execution of LLC quality plan, and providing oversight of the performance of external manufacturers engaged in providing finished products bearing the LLC name. Participates in LLC Management Team meetings to assure compliance with applicable regulatory strategies and regulations. Ensures sites fulfill all Quality Agreement requirements. Leads the plant staff in the understanding, development and deployment of key strategies, continuous improvement and customer focus. Develops and disseminates strategy for talent attraction, development and retention to enhance the Quality MAKE talent pipeline. Ensures manufacturing sites have appropriate resources with the right competencies to execute the Quality System. Provides active link and partnership between the sites, franchise partners, regions and enterprise functions. Partners with the respective management for their sphere of influence to develop and support initiatives and responses to internal issues. Fosters resource leverage across plants and regions, ensures alignment or harmonization where required and/or appropriate. Executes responses to field actions and coordinates global response in partnership with the franchise Quality leadership and enterprise functions. Oversee release systems of all products manufactured in plants. Oversee & direct participation in quality systems improvement, cost reduction, cycle time reduction, & profit improvement programs. Collaborate with all business representatives to further corporate goals, values & objectives Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001). Other responsibilities may be assigned & not all responsibilities listed may be assigned. Qualifications EDUCATION and/or EXPERIENCE BS in Business, Life Science, Physical Science or Engineering required, Master’s Degree preferred. Minimum of 10 years of combined experience in Regulatory, Compliance, Quality Management and/or Operations in Medical Devices, Consumer or pharmaceutical environment is required; medical devices is preferred. Minimum of 5 years with Supervisory experience is required. Experience successfully managing a plant- based, multi-site, and multi-geographical organization (Quality or Operations) is required. Experience successfully managing a multinational department and/or a significant project is required. Experience driving high performing cross-functional and indirect teams that deliver results is required. Experience in statistical tools, and process validations are preferred. Knowledge, Skills, Abilities, Certifications/License and Language Bilingual, English and Spanish. Strong project management and influencing skills. A certification in Process Excellence certification (i.e. Black Belt) from a recognized program is preferred. Experience in actively participating in FDA or other Health Authority inspections is preferred. ASQ Quality Manager Certification is preferred. ISO 9001 Lead Assessor certification is preferred. Proficiency with engineering analysis and statistical software. Well-developed problem solving skills. Outstanding communication (written and verbal), negotiation and leadership skills. Ability to listen, learn, teach, and think strategically are traits that are required for success in this role. Knowledge of practices and policies of regulatory agencies. Initiative in innovative approaches to Quality and Regulatory solutions and applications in a fast paced changing business environment is preferred. Very strong partnering, influence and change management skills are required. Ability to foster a productive team-oriented environment, handle multiple assignments, and display flexibility in response to an environment with rapidly shifting priorities is required Ability to travel up to 40% of the time is required. Disclaimer: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. This is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
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