Design Quality Associate Director - Sustaining Engineering HEREDIA

Additional Locations: Costa Rica-Heredia

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role

Design Quality assurance and compliance Subject Matter Expert (SME) on multiple products, systems, and technologies.  Devotes a significant portion of time to leadership at the regional and divisional level. Establishes and maintains expertise in Design Quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  Provides Design Quality guidance and support for technical development, regulatory and operational concepts/systems/services.  Influences departmental, functional, site, and divisional Design Quality goals and priorities.  Mentors cross-functional stakeholders on Design Quality processes and procedures, as appropriate.

Your responsibilities include:

• Oversee the continued organization and development of PI Sustaining Design Assurance team, providing Design Quality expertise and support for technical advancement, regulatory compliance, and operational systems and services throughout ongoing projects.
• Lead the growth and direction of the Design Assurance team dedicated to Sustaining Engineering.
• Work collaboratively with R&D, Regulatory, and Operations.
• Support and Maintenance of IO&E and Vascular products.
• Support the preparation and staffing for Design Audits.
• Responsible for ensuring the safety, quality, and compliance of launched products, continuously improve product performance and commercial value throughout the product life cycle using the Best4 strategy as a basis in several BSC sites across the network.
• Quality Leader of 90+ product families including guidewires, catheters, accessories, inflation devices and embolization coils, responsible for~ 48 employees; including managers, engineers, and technical writers
• Responsible for the communication and documentation of internal information related to design quality assurance and compliance, as appropriate
• Applies effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving divisional design quality issues
• Leads the execution of streamlined quality systems and methodologies, which effectively identify and resolve design quality issues
• Keeps abreast of and act as an expert (within division) for current applicable worldwide regulatory & design quality assurance and compliance requirements
• Leads and supports departmental, functional and divisional design quality goals and priorities
• Acts as leader (divisional) or team member (global) in supporting design quality disciplines, decisions, and practices
• Builds quality into all aspects of work by maintaining compliance to all quality requirements
• Leads and participates in various design quality assurance and compliance improvement projects as a (divisional) subject matter expert
• Other duties as necessary or required by the department, division, or organization

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.

For those individuals that supervise others, the following statements are applicable:

• 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

Required Qualifications:

• Licenciature or Master degree in Business Administration, Industrial Engineering or Field Related plus 12 years of related work experience or an equivalent combination of education and work experience
• 10-11 years of experience leading a large team/organization
• Experience in the Medical Device Industry
• Additional skill Coaching,Strategic Thinking,Influence,Global Perspective,Communication, Relationship Building, Innovation, People management, Leadership
• English level desire C1+
• Please submit Resume in English

Requisition ID: 614172

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.