Principal Technical Writer
About The Position
Boston Scientific is seeking an experienced Principal Technical Writer to join the Global Quality Systems organization. In this highly visible role, you will lead the development, governance and continuous improvement of enterprise-level procedures, work instructions, training materials and knowledge resources that support Corrective and Preventive Action (CAPA), Product Inquiry Reports (PIR), Nonconformance Event Process (NCEP) and related Global Quality System processes. This incumbent will collaborate with global process stewards, quality leaders, business analysts and digital teams to ensure quality system documentation is clear, compliant, user-focused and audit-ready. In addition, you will own the Corporate CAPA, PIR, NCEP and Nonconforming Material (NCM) SharePoint knowledge environment, establishing best practices for content governance, knowledge management and enterprise-wide communication. This role also plays a critical part in supporting enterprise eQMS implementation activities, Project Guardian initiatives and ongoing Global Quality Systems transformation efforts. This role follows a hybrid work model requiring employees to be in their assigned local office at least three days per week. This position may be based in our Arbor Lakes, Arden Hills or Maple Grove, Minnesota; Marlborough, Massachusetts; or Spencer, Indiana. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Requirements
- 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.
Nice To Haves
- Demonstrated experience supporting CAPA, nonconformance, complaint handling, field action or other quality management system processes.
- Demonstrated experience supporting enterprise system implementations, including eQMS, PLM, ERP or similar platforms.
- Proven experience using Microsoft Visio, Microsoft 365 applications and learning management systems.
- Familiarity with change management principles and organizational learning methodologies.
- Knowledge of document governance, knowledge management best practices and continuous improvement methodologies.
- Proven experience supporting regulatory inspections or internal and external quality audits.
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.
Benefits
- See www.bscbenefitsconnect.com
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What This Job Offers
Job Type
Full-time
Career Level
Principal
