Senior Technical Writer, Global Quality Systems & eQMS

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 join the Global Quality Systems organization. You will lead the development, governance and continuous improvement of enterprise-level procedures, work instructions, training materials and knowledge resources that support CAPA, PIR, NCEP and related processes.

The role collaborates with global process stewards, quality leaders, business analysts and digital teams to ensure clear, compliant, user-focused documentation and

Qualifications

• Bachelor's degree in a technical field or related discipline.
• 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, user-focused documentation.
• Strong document management, editing and technical writing skills.
• Experience administering SharePoint sites and managing enterprise knowledge content.
• Ability to collaborate across global, cross-functional teams.

Responsibilities

• Author, revise and maintain global procedures, work instructions, guidance documents and templates for Global Quality Systems.
• Develop documentation compliant with FDA QMSR, 21 CFR Part 820, ISO 13485, EU MDR and related standards.
• Drive consistency in terminology, documentation standards and process structure across Corporate Quality processes.
• Collaborate with global stakeholders to develop future-state procedures for enterprise eQMS implementation.
• Support Project Guardian initiatives with standardized work instructions and guidance.
• Own and maintain the Corporate CAPA, PIR, NCEP and NCM SharePoint knowledge environment.
• Develop learning content and knowledge resources to support adoption of new quality processes.
• Communicate procedural updates and ensure organizational awareness of changes.
• Identify opportunities to improve documentation quality, usability and efficiency.

Skills

Technical writing

Regulatory compliance

Cross-functional collaboration

Document management

Editing

Education

Bachelor's degree in Technical Communications or related

Tools

SharePoint

Microsoft Visio

Microsoft 365

Job description

Boston Scientific is seeking an experienced Principal Technical Writer to join the Global Quality Systems organization. You will lead the development, governance and continuous improvement of enterprise-level procedures, work instructions, training materials and knowledge resources that support CAPA, PIR, NCEP and related processes.

The role collaborates with global process stewards, quality leaders, business analysts and digital teams to ensure clear, compliant, user-focused documentation and