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Marlboro, MA
Source: Boston Scientific careers · View original posting
From Boston Scientific's posting. “We” and “our” refer to the employer.
Spencer Gregory Hale
Senior Cybersecurity Quality Systems Engineer
The Senior Cybersecurity Quality Systems Engineer is a member of the Global Software Quality organization and serves as the Quality Systems subject matter expert for medical device cybersecurity. This role provides operational support to product development teams by independently reviewing cybersecurity documentation and objective evidence to ensure alignment with the Boston Scientific Quality System, Global Software Quality procedures, and applicable regulatory requirements.
The Senior Cybersecurity Quality Systems Engineer evaluates the completeness, consistency, and technical sufficiency of cybersecurity design outputs and supporting documentation to verify that cybersecurity activities have been performed in accordance with established Quality System processes and industry expectations.
The role provides objective feedback, identifies opportunities for improvement, and partners with cross-functional teams to strengthen cybersecurity quality, compliance, and continuous improvement throughout the product lifecycle.
In addition, this role serves as a key resource within Global Software Quality by monitoring evolving cybersecurity regulations, standards, and guidance and translating those expectations into Quality System procedures, review methodologies, and organizational best practices.
Your responsibilities will include
Serve as the Global Software Quality subject matter expert for cybersecurity Quality System processes supporting medical devices, software, and connected systems.
Perform independent reviews of cybersecurity documentation and product development deliverables to ensure alignment with the Boston Scientific Quality System, Global Software Quality procedures, and applicable regulatory requirements.
Review cybersecurity objective evidence, including threat models, cybersecurity risk assessments, security requirements, software architecture documentation, verification and validation evidence, vulnerability assessments, Software Bill of Materials (SBOM), and residual cybersecurity risk documentation.
Assess the completeness, traceability, consistency, and technical sufficiency of cybersecurity documentation to determine whether cybersecurity activities have been appropriately planned, executed, documented, reviewed, and approved.
Provide objective feedback and practical recommendations to product teams regarding cybersecurity documentation, Quality System compliance, and process improvements.
Partner with Research & Development, Product Security, Systems Engineering, Software Engineering, Regulatory Affairs, and Quality organizations to resolve documentation and process gaps while maintaining an independent Quality Systems perspective.
Support cybersecurity design reviews and development milestone reviews by evaluating cybersecurity deliverables against internal procedures and external regulatory expectations.
Develop, maintain, and continuously improve Global Software Quality procedures, work instructions, review checklists, templates, and guidance related to medical device cybersecurity.
Monitor changes to global cybersecurity regulations, standards, and industry guidance and assess their impact on the Boston Scientific Quality System.
Lead implementation of Quality System updates resulting from new cybersecurity regulations, standards, and guidance.
Identify systemic trends and recommend continuous improvements to cybersecurity Quality System processes across the organization.
Support internal quality activities, regulatory inspections, CAPA investigations, and quality improvement initiatives involving cybersecurity processes and documentation.
Mentor and educate cross-functional teams on cybersecurity Quality System expectations and documentation best practices.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation
non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions
: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any
other protected class.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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