Boston Scientific
Design Quality Manager - Interventional Oncology & Embolization
Boston Scientific, Osseo, Minnesota, United States, 55311
Design Quality Manager - Interventional Oncology & Embolization
Join Boston Scientific as a Design Quality Manager and lead the quality assurance and design control functions for the Interventional Oncology & Embolization (IO&E) organization. Responsibilities
Assist in and/or manage functional deliverables and ensure technical excellence for Sustaining Engineering and New Product Development. Drive functional excellence in Design Quality Assurance by providing leadership, coaching, and mentoring on product design and development, including Risk Management, Design Controls, and Post-Market Surveillance. Provide leadership, guidance, and approval regarding Quality initiatives including product performance. Review and approve verification and validation plans, protocols, reports, and non-conforming product assessments. Work cross-functionally in identifying and resolving technical issues, taking a proactive role in collaborating across the organization to mitigate issues. Work with project managers and functional leaders (R&D, Supplier Quality Engineering, Marketing, and Regulatory) to understand priorities, plan resources, and allocate time. Explore opportunities for staff to learn about new initiatives and participate on new projects. Drive and evaluate process and results for project and department objectives. Recruit, hire, train, and develop world-class staff. Management Requirements
Lead a group or team of employees in the achievement of organizational goals, guide, coach, direct, and develop direct reports, and drive best practices throughout their organization. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Direct and control the activities and budget of one or more functional areas and/or projects/programs. Monitor and ensure compliance with company policies and procedures (e.g., federal/country and regulatory requirements). Influence others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Required Qualifications
B.S. Degree in engineering such as Mechanical Engineering, Electrical Engineering, Materials Science and/or Biomedical Engineering. Bachelor's degree plus 8 years of related work experience or an equivalent combination of education and work experience. Proven technical leadership and project management skills in medical device design, development, commercial launch, and product sustainment. Knowledge/Experience of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations. 2+ years of experience mentoring Boston Scientific Corporation is an equal opportunity employer. We proudly embrace an inclusive and diverse environment and are committed to providing equal employment opportunities for all individuals.
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Join Boston Scientific as a Design Quality Manager and lead the quality assurance and design control functions for the Interventional Oncology & Embolization (IO&E) organization. Responsibilities
Assist in and/or manage functional deliverables and ensure technical excellence for Sustaining Engineering and New Product Development. Drive functional excellence in Design Quality Assurance by providing leadership, coaching, and mentoring on product design and development, including Risk Management, Design Controls, and Post-Market Surveillance. Provide leadership, guidance, and approval regarding Quality initiatives including product performance. Review and approve verification and validation plans, protocols, reports, and non-conforming product assessments. Work cross-functionally in identifying and resolving technical issues, taking a proactive role in collaborating across the organization to mitigate issues. Work with project managers and functional leaders (R&D, Supplier Quality Engineering, Marketing, and Regulatory) to understand priorities, plan resources, and allocate time. Explore opportunities for staff to learn about new initiatives and participate on new projects. Drive and evaluate process and results for project and department objectives. Recruit, hire, train, and develop world-class staff. Management Requirements
Lead a group or team of employees in the achievement of organizational goals, guide, coach, direct, and develop direct reports, and drive best practices throughout their organization. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Direct and control the activities and budget of one or more functional areas and/or projects/programs. Monitor and ensure compliance with company policies and procedures (e.g., federal/country and regulatory requirements). Influence others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Required Qualifications
B.S. Degree in engineering such as Mechanical Engineering, Electrical Engineering, Materials Science and/or Biomedical Engineering. Bachelor's degree plus 8 years of related work experience or an equivalent combination of education and work experience. Proven technical leadership and project management skills in medical device design, development, commercial launch, and product sustainment. Knowledge/Experience of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations. 2+ years of experience mentoring Boston Scientific Corporation is an equal opportunity employer. We proudly embrace an inclusive and diverse environment and are committed to providing equal employment opportunities for all individuals.
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