Senior Technical Writer, Global Quality Systems (Hybrid)

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking an experienced Principal Technical Writer to lead the development, governance and continuous improvement of enterprise-level quality system documentation. This role focuses on CAPA, PIR, NCEP and NCM processes, ensuring clarity, compliance and audit readiness across global teams.

You will collaborate with process stewards, quality leaders and digital teams to create user-focused procedures, work instructions and training materials that support eQMS implementations

Qualifications

• Minimum Bachelor's degree in Technical Communications, Quality, Engineering, Life Sciences, Regulatory Affairs or a 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.
• Demonstrated ability to translate complex technical concepts into clear, concise and user-focused documentation.
• Strong document management, editing and technical writing skills.
• Proven experience administering SharePoint sites and managing enterprise knowledge content.
• Strong collaboration and communication skills with the ability to work effectively across cross-functional, global teams.

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 methodologies.

Skills

Technical writing

Document management

Cross-functional collaboration

SharePoint administration

Editing and proofreading

Clear communication

Education

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

Tools

Microsoft Visio

Microsoft 365 applications

SharePoint

eQMS

PLM/ERP systems

Job description

Boston Scientific is seeking an experienced Principal Technical Writer to lead the development, governance and continuous improvement of enterprise-level quality system documentation. This role focuses on CAPA, PIR, NCEP and NCM processes, ensuring clarity, compliance and audit readiness across global teams.

You will collaborate with process stewards, quality leaders and digital teams to create user-focused procedures, work instructions and training materials that support eQMS implementations