Boston Scientific
Quality Director - Endoscopy
Boston Scientific, Marlborough, Massachusetts, United States, 01752
Quality Director - Endoscopy
This is an exciting opportunity for a strong leader to work as part of a high performing, cross functional Development & Sustaining Organization in Boston Scientific's Endoscopy Division. Endoscopy is one of Boston Scientific's fastest growing divisions
and its development and sustaining organization has a global footprint
with teams based in the US, Costa Rica, Ireland, India & China. You will be part of the Quality Leadership team supporting the Endoscopy division
with specific ownership for Design Quality Assurance for several franchises, as well as the APAC focused New Business Development Quality team. You will be located at the Marlborough campus and can expect to travel to and provide support for other sites as required. You will partner daily with your R&D, Regulatory, Global Supply Chain, PMO, Clinical, New Business Development and Marketing peers in achieving new product development, commercialization, and product sustainment. Your responsibilities will include: Ensure product safety, reliability and high quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product life cycle. Ensure efficient compliance to all applicable regulations through the implementation of a robust company quality system and through communication/reporting to regulatory authorities. Provide overall leadership to the team in the achievement of organizational goals. Recruit, coach and develop organizational talent. Assure continuous improvement in product performance by incorporating learnings into new product development. Employ lean methodologies to improve the efficiency of the Quality System. Develops and executes organizational and operational policies and processes that affect one or more groups by utilizing technical/professional knowledge and skills. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Keep the organization's vision and values at the forefront of decision making and action, including directing and controlling the activities and budget. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. What we're looking for in you: Minimum qualifications: Minimum of a Bachelor's degree Minimum of 10 years of related experience in Quality Engineering Minimum of 5 years of direct management experience in Quality Engineering Regulatory compliance experience in the areas of medical devices Experience as a strong inclusive leader with proven experience collaborating with peers and network. Experience working with Global teams Preferred qualifications: Advanced degree in technical fields Experience leading technical teams Experience leading globally based teams Prior R&D, Design Assurance, Product and/or Process Development Experience working with Manufacturers/Suppliers in APAC/China
This is an exciting opportunity for a strong leader to work as part of a high performing, cross functional Development & Sustaining Organization in Boston Scientific's Endoscopy Division. Endoscopy is one of Boston Scientific's fastest growing divisions
and its development and sustaining organization has a global footprint
with teams based in the US, Costa Rica, Ireland, India & China. You will be part of the Quality Leadership team supporting the Endoscopy division
with specific ownership for Design Quality Assurance for several franchises, as well as the APAC focused New Business Development Quality team. You will be located at the Marlborough campus and can expect to travel to and provide support for other sites as required. You will partner daily with your R&D, Regulatory, Global Supply Chain, PMO, Clinical, New Business Development and Marketing peers in achieving new product development, commercialization, and product sustainment. Your responsibilities will include: Ensure product safety, reliability and high quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product life cycle. Ensure efficient compliance to all applicable regulations through the implementation of a robust company quality system and through communication/reporting to regulatory authorities. Provide overall leadership to the team in the achievement of organizational goals. Recruit, coach and develop organizational talent. Assure continuous improvement in product performance by incorporating learnings into new product development. Employ lean methodologies to improve the efficiency of the Quality System. Develops and executes organizational and operational policies and processes that affect one or more groups by utilizing technical/professional knowledge and skills. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Keep the organization's vision and values at the forefront of decision making and action, including directing and controlling the activities and budget. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. What we're looking for in you: Minimum qualifications: Minimum of a Bachelor's degree Minimum of 10 years of related experience in Quality Engineering Minimum of 5 years of direct management experience in Quality Engineering Regulatory compliance experience in the areas of medical devices Experience as a strong inclusive leader with proven experience collaborating with peers and network. Experience working with Global teams Preferred qualifications: Advanced degree in technical fields Experience leading technical teams Experience leading globally based teams Prior R&D, Design Assurance, Product and/or Process Development Experience working with Manufacturers/Suppliers in APAC/China