Senior Quality Systems Engineer

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 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 Systems Engineer will be part of our growing Global Capital Equipment Quality Assurance team supporting BSC’s high growth Medical Electrical Equipment [commonly referred to as Capital Equipment (CE)] portfolio. The Quality System engineer will work closely with CE Service and Service Quality teams globally to support them in the matters of Quality metrics, CAPA process and mentoring, Quality System signals trending. The role will also be responsible for actively partnering with CE Quality end-to-end process subject matter experts. This role will allow the incumbent to be exposed to all divisions and regions within BSC; and develop a global perspective and network. The incumbent will have opportunities to understand and impact processes that directly influence BSC’s customer experience. 

 

This position can be located at BSC locations across North America, Latin America, and Europe.

Your responsibilities include:

• Understand BSC’s Quality System and Quality Systems Management Process.
• Develop, maintain and trend Quality metrics supporting CE Service business.
• Own Quality metrics review process(es) related to CE.
• Support audits related to Capital Equipment.
• Manage process based CAPAs/VIPs to address nonconformances and improvements.
• Trend CAPAs and NCEPs in CE Service process.
• Provide mentoring for other owners of NCEP and CAPA related to CE Service.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Key participant in Capital Equipment communities, to actively collaborate with the company’s strategy of making Capital Equipment a competitive advantage for BSC.
• Partnering with Capital Equipment Service process stakeholders to ensure compliance to BSC Quality System requirements and external regulations for Capital Equipment.  
• Partner with CE Process SMEs to interpret laws, regulations, standards and guidance and drive improvements and/or clarifications in BSC Quality System.
• Support and lead improvement projects to sustain Best4 Quality Strategy, ensuring Best Culture, Best Agility, Best Performance and Best Compliance.
• Requires strong engagement with distribution and commercial region teams to understand business requirements and help set up or improve existing Quality System processes to support the business.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
• Contribute actively to relevant internal BSC global Communities of Practice.
• Work across the globe with flexible working hours to support BSC teams across the globe.

 

Required qualifications:

• Bachelor's degree
• Minimum of 5 years of related work experience
• Demonstrated problem solving skills, preferably in the CAPA process
• Proficient in use of Excel & PowerPoint

 
Preferred qualifications:

• Ability to understand procedural requirements and evaluate documents to ensure compliance to all applicable regulations and requirements
• Strong verbal and written communication, project management, and organizational skills
• Ability to influence and indirectly lead including in challenging situations
• Data analytics skills
• Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential

    
 

Requisition ID: 579139

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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