Quality Manager I

Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer and marketer of medical devices.

Will predominantly oversee Supplier Quality Assurance functions for the site. Manages a professional staff which develops, establishes, and maintains processes and procedures to assure that product quality and process performance conform to internal specifications, external regulatory agency requirements, and national and international standards.

**Key Responsibilities:** - Establish and support a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for the area supported. - Ensure employees are trained to do their work and their training is documented. - Manages a team of quality engineers and technicians while also ensuring that the staff has the necessary skills to ensure compliance in their responsible areas. - Provide Quality support and resources to Production Unit Team. - Performs responsibilities required by the Quality System and other duties as assigned or requested. - Participates on project teams and assignments, facilitating or leading teams as necessary. - Formulates quality engineering policies and procedures. - Assists in and/or manages functional deliverables to assure: processes are operating at expected levels; products currently in commercial distribution conform to applicable domestic and international standards; risks associated with use of products currently in commercial distribution remain at a as low as reasonably practicable level. - Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff. - Responsible for annual budget and headcount resources for department. - Assists in and/or determines appropriate staff levels, schedules and resources. - Works with functional/project managers to understand priorities and plan resource and time allocation accordingly. - Assists in identifying and developing department tools. - Encourages problem-solving processes leading to leveragability of solutions across functions. - Maintains and enhances cross-functional team relationships. - Works cross-functionally in identifying and resolving technical issues. - Allocates/re-allocates internal and external resources, as needed with advice from Sr. Quality management. - Drives and evaluates project and department progress and results. **Management Responsibilities:** - 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. - May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations. - Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

- Bachelor's degree in Quality or Engineering related area. - Must have lead auditor certification to be considered and minimally 7-10 years of experience in the Medical Device industry, with a significant amount of that time supporting QA Operations. **Quality Systems Requirements:** - In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. - Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. - Establishes and promotes a work environment that supports the Quality Policy and Quality System.