Senior Technical Writer, Global Quality Systems

Boston Scientific; Indiana (PA); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific seeks an experienced Principal Technical Writer to lead the development, governance and continuous improvement of enterprise-level quality system documentation, including CAPA, PIR, NCEP and Nonconforming Material (NCM) processes. You will collaborate with global process stewards, quality leaders and digital teams to ensure content is clear, compliant, user-focused and audit-ready.

This role owns the Corporate CAPA, PIR, NCEP and NCM SharePoint knowledge environment,

Qualifications

• Bachelor’s degree in a technical or regulatory field.
• 8+ years’ experience in technical writing within a regulated industry.
• Experience authoring and maintaining controlled procedures and quality system documentation.
• Ability to translate complex technical concepts into clear, concise, user-focused documentation.
• Strong document management, editing and technical writing skills.
• Experience administering SharePoint and enterprise knowledge content.
• Strong collaboration and communication across 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 QMSR, 21 CFR Part 820, ISO 13485, EU MDR and other requirements.
• Drive consistency in terminology, documentation standards, process flows and structure across Corporate Quality processes.
• Collaborate with global stakeholders to develop future-state procedures and user guidance for enterprise eQMS.
• Support Project Guardian initiatives by creating standardized work instructions and documentation for corrective actions.
• Own and maintain the Corporate CAPA, PIR, NCEP and NCM SharePoint knowledge environment.
• Develop and maintain learning content and knowledge resources to support adoption of new quality processes.
• Communicate procedural updates to ensure organizational awareness of changes.
• Identify opportunities to improve documentation quality, usability and efficiency.

Skills

Technical writing

SharePoint administration

Quality systems

Cross-functional collaboration

Documentation governance

Education

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

Tools

SharePoint

Microsoft Visio

Microsoft 365

Learning management systems

Job description

Boston Scientific seeks an experienced Principal Technical Writer to lead the development, governance and continuous improvement of enterprise-level quality system documentation, including CAPA, PIR, NCEP and Nonconforming Material (NCM) processes. You will collaborate with global process stewards, quality leaders and digital teams to ensure content is clear, compliant, user-focused and audit-ready.

This role owns the Corporate CAPA, PIR, NCEP and NCM SharePoint knowledge environment,