Design Assurance Director - Waltham, United States - Boston Scientific Corporation

Boston Scientific Corporation

Verified Company

Waltham, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Work mode:
Hybrid
Onsite Location(s):Waltham, MA, US, 02138
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and highperforming employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions.

About the role:

The Design Assurance Director is a unique opportunity for a strong leader to work on a high-performing, cross-functional product development team to design and maintain world-class Electrophysiology Systems.

The Design Assurance Director will serve as the Site Head of Quality (SHOQ) in our Waltham MA and Montreal design sites and will have primary Quality Assurance leadership/oversight for the rapidly growing Pulse Field Ablation (PFA) Franchise, having a direct interaction with Montreal, Heredia and Arden Hills sites.

Your key responsibilities will include:

Recruit, coach and develop organizational talent.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team.
Keep the organization's vision and values at the forefront of decision making and action.
Demonstrate effective change leadership.
Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.
Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO, etc.).
Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects.
Own and drive deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
Own and drive commercial product monitoring and all related product sustainment activities.
Develop and implement quality strategies; seeks innovative approaches to attaining quality goals.
Directly interface with internal and external audit activities.

Required Qualifications:

Minimum of a Bachelors degree
Minimum of 10 years of related experience
Minimum of 5 years of direct or indirect management experience
Regulatory compliance experience in the areas of medical devices

Preferred Qualifications:

Advanced degree in technical fields
Experience leading technical teams
Prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience

Requisition ID:583960At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.- Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.-
Nearest Major Market:Cambridge

Nearest Secondary Market:
Boston

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R&D Engineer, Compliance, Manufacturing Engineer, QA, Quality Assurance, Engineering, Legal, Quality, Technology