Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer and marketer of medical devices. By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce. For more information, please visit www.bostonscientific.com.
Global Design Assurance is seeking a Quality Systems Manager II to develop, establish and maintain quality assurance programs, policies, processes, procedures and controls related to Design Assurance, Production/Process Controls and Risk Management ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. Review, analyze and report quality discrepancies related to areas of responsibility and develop disposition and corrective actions for recurring discrepancies. Interface with manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities and solutions. Serve as the liaison between the company and various governmental agencies as required.
DUTIES AND RESPONSIBILITIES
· Drive Quality projects.
· Provide significant guidance and approval regarding technical strategies and approaches.
· Provide guidance and training to staff, assist subordinates in attaining career goals, motivate individuals to achieve results, recruit and maintain a high quality staff.
· Determine appropriate staff levels, schedules and resources
· Drive the development of department tools and methodologies.
· Determine project staff assignments and schedules work to meet completion dates and deliverables.
· Establish cross-functional team relationships
· Provide an overview of the function and role of his/her group, technical skill sets, to other groups and/or divisions.
· Work cross-functionally in identifying and resolving technical issues.
· Drive and evaluate project and department progress and results.
· May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
· Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
· Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
· Assure appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the BSC Quality Policy.
· Establish and promote a work environment supporting the Quality Policy and Quality System
· Audit SME for Design Controls/Risk Management
· Bachelor’s Degree, Engineering or related discipline
· Minimum 10 years’ experience working in a Quality discipline in a Medical Device manufacturing environment
· Minimum 5 years’ of direct reports management experience
· Working knowledge of FDA Quality Regulations (CFR820) and ISO 14971 / 13485 requirements
· Must be willing and able to travel up to 20% between all facilities
· ASQ Certified
· Experience evaluating staff performance and assist in career development planning
Boston Scientific knows that nothing is simple in matters of the heart. The company makes medical supplies and devices used to diagnose and...