Senior Quality Systems Specialist

Additional Locations:  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 high-performing 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 Senior Quality System Specialist will serve as a Quality representative to improve awareness, visibility, and communication on quality business process change and various Technical service-related initiatives related to Medical Electrical Equipment. Collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes, and maintains quality methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. Provide compliance guidance and support for technical development concepts, regulatory, operational, or systems/services. May mentor cross-functional stakeholders on implementing Quality processes and procedures as appropriate.

Your responsibilities include:

• Works closely with the Regional and Global Capital Equipment Technical Services (CETS),in Implementing, maintaining and improving the Global Quality System.
• Act as an SME and support operational quality issues over medical electrical equipment.
• Support Document updates and review from and communicate impact and drive resolutions with the stakeholders.
• Act as a Quality Representative on Regional and Global Projects.
• Proactively identifies improvement opportunities, implements best-in-class Quality Engineering practices, and implements/manages improvement projects.
• Performs Quality Assessments, identifies impact and drives resolutions while supporting Local, regional and Global process changes.
• Support for site-level internal/external audits and if needed, act as Subject Matter Expert (SME) in audits.
• Documents non-conformances, evaluates impact, and makes recommendations for corrective actions, ensuring good recording and administration and timely closure of all related NCEP or CAPA activities/actions.
• Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally.
• Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.
• Understands, interprets, and applies Documentation Control principles and processes to ensure compliance with the Global Quality System.
• Drives awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific.

 
What we’re looking for in you:

• Bachelor’s degree at a minimum required
• Experience working in medical device (or Medical Electrical Equipment ) industry required
• 5-7 Years of experience required; Relevant functional experience within the areas of Distribution/Field Inventory management/Technical Services is preferred
• Demonstrated capability in collaborating and partnering within a global environment/ matrix organization
• Project management skills
• Knowledge about ISO 13485, IEC 60601 and IEC 62353 is a plus.
• Experience working in cross-functional teams and driving projects to completion
• Proven track record in building a continuous improvement culture based on Business Excellence principles and methodologies
• Experience on VIP system and implementation of Value improvement projects
• Ability to work independently and as a member of a team in a dynamic environment
   

Requisition ID: 576333

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!