Senior Technical Writer, Global Quality Systems & Compliance

Boston Scientific; Marlboro (MA); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific seeks an experienced Principal Technical Writer to lead development and governance of enterprise-level quality system documentation, including CAPA, PIR, NCEP and NCM processes, across the Global Quality Systems organization. You will collaborate with process stewards, quality leaders, business analysts and digital teams to ensure audit-ready content.

The role requires a Bachelor's in a related field and 8+ years in regulated technical writing, with strong SharePoint,

Qualifications

• Minimum Bachelor's degree in Technical Communications, Quality, Engineering, Life Sciences, Regulatory Affairs or related discipline.
• Minimum of 8 years' experience in technical writing within a regulated industry.
• Experience authoring and maintaining controlled procedures, work instructions and quality system documentation.
• Ability to translate complex technical concepts into clear, user-focused documentation.
• Strong document management, editing and technical writing skills.

Responsibilities

• Author, revise and maintain global procedures, work instructions, guidance documents, templates and job aids supporting Global Quality Systems.
• Develop documentation that complies with FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, EU MDR and other applicable regulatory and internal quality system requirements.
• Drive consistency in terminology, documentation standards, process flows and procedural structure across Corporate Quality processes.
• Partner with global process stewards, business analysts, information technology teams and subject matter experts to develop future-state procedures and user guidance supporting enterprise eQMS implementation.
• Support Project Guardian initiatives by creating standardized work instructions, execution guidance and documentation that enables sustainable corrective actions.
• Own and maintain the Corporate CAPA, PIR, NCEP and NCM SharePoint knowledge environment, ensuring content is accurate, current, accessible and governed according to established standards.
• Develop and maintain learning content and knowledge resources that support adoption of new quality processes, systems and technologies.
• Collaborate with Quality Systems leaders and process stewards to communicate procedural updates and ensure organizational awareness of process changes.
• Identify opportunities to improve documentation quality, usability and efficiency through standardization and continuous improvement.

Skills

Technical writing

Regulated industry

SharePoint administration

Cross-functional collaboration

Documentation standards

Education

Bachelor's degree in Technical Communications, Quality, Engineering, Life Sciences, Regulatory Affairs or related discipline

Tools

SharePoint

Microsoft Visio

Microsoft 365 applications

Learning management systems

Job description

Boston Scientific seeks an experienced Principal Technical Writer to lead development and governance of enterprise-level quality system documentation, including CAPA, PIR, NCEP and NCM processes, across the Global Quality Systems organization. You will collaborate with process stewards, quality leaders, business analysts and digital teams to ensure audit-ready content.

The role requires a Bachelor's in a related field and 8+ years in regulated technical writing, with strong SharePoint,