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 the Global Quality Systems Team supporting the Headquarters site.

Focus areas include supporting the regulatory requirements process, including monitoring, tracking, and driving completion of new or revised large scale regulatory requirements that span across BSC sites and/or Quality System functions. This role will also support global Notified Body relationships and global certificate management to ensure BSC remains complaint to EU MDR and other regulations. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary.

This role acts as the representative to improve awareness, visibility, and communication on global initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Partner with functional teams across all divisions to drive and improve processes. 

 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

 

Relocation assistance is not available for this position at this time.

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

Your responsibilities will include:

• Supporting the organization’s global processes for identifying, tracking, monitoring and regulatory requirements.
• Support Notified Body relationships, including audit scheduling and management, assessing quality system changes for reportability, and ensuring strong communication between Boston Scientific and the Notified Body.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advise on potential improvements or enhancement to quality systems and processes in the company.
• Lead projects within or that support the Quality System Management team.
• Own NCEP and CAPA records as applicable to the role.
• Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals.
• Support internal and external audits and audit responses on an as needed basis.

 

Required Qualifications:

• Bachelor’s degree in science and/or engineering and 6+ years medical device/Quality System experience or Master’s degree and 4+ years of medical device/Quality System experience.
• Strong project management skills: ability to develop a project plan and manage a project through execution with minimal oversight
• Experience with NCEPs and CAPAs (non-conforming events and the corrective action process).
• Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR.
• Proficiency with Microsoft Office suite, including SharePoint.

 

Preferred Qualifications:

• Bachelors degree in engineering or equivalent experience
• Experience with working with Notified Bodies and certificate management.
• Experience with regulations, including EU MDR, 21 CFR 820, MDSAP program and ISO 13485. 
• Demonstrated competency working cross functionally and globally.
• Strong communication and presentation skills.
• Ability to develop effective, positive interpersonal relationships.
• Driven, energetic, self-assured professional with high personal integrity
• Experience writing and implementing quality system procedures
• Familiarity with BSC systems such as Windchill, eCAPA

 

 

 

Requisition ID: 609843