Boston Scientific is looking to solve challenges related to regulatory compliance and quality system management by hiring a Senior Quality Systems Engineer. This role will support global regulatory requirements, manage Notified Body relationships, and ensure ongoing compliance with standards like EU MDR and ISO 13485, ultimately aiming for best-in-class audit performance and process improvement.
Requirements
- 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.
- Experience with working with Notified Bodies and certificate management.
- Experience with regulations, including EU MDR, 21 CFR 820, MDSAP program and ISO 13485.
- Experience writing and implementing quality system procedures
- Familiarity with BSC systems such as Windchill, eCAPA
Responsibilities
- 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.
Other
- Bachelor’s degree in science and/or engineering and a minimum of 6 years medical device/Quality System experience or Master’s degree and a minimum of 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
- Demonstrated competency working cross functionally and globally.
- Strong communication and presentation skills.
- Ability to develop effective, positive interpersonal relationships.
