Global Quality Systems Principal Technical Writer

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

Job summary

Boston Scientific in Marlborough, MA, seeks a Principal Technical Writer to lead enterprise-quality documentation, CAPA, PIR, NCEP and NCM processes within Global Quality Systems. Hybrid work model, content governance, regulatory alignment and audit readiness.

You will collaborate with global process stewards, quality leaders, business analysts and digital teams to ensure clear, compliant documentation across the quality systems and eQMS initiatives.

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.

Skills

Technical Writing

Regulated Industry

SharePoint Admin

Documentation Governance

Cross-functional Collab

Education

Bachelor's degree in Technical Communications

Related discipline

Tools

SharePoint

Microsoft Visio

MS 365

LMS

Job description

Boston Scientific in Marlborough, MA, seeks a Principal Technical Writer to lead enterprise-quality documentation, CAPA, PIR, NCEP and NCM processes within Global Quality Systems. Hybrid work model, content governance, regulatory alignment and audit readiness.

You will collaborate with global process stewards, quality leaders, business analysts and digital teams to ensure clear, compliant documentation across the quality systems and eQMS initiatives.