Quality Assurance Document Control Specialist

This job is with Boston Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Additional Location(s):
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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role:

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.
The Quality Assurance Document Control Specialist is responsible for maintaining and continuously improving documentation and records management quality systems in compliance with company and regulatory requirements. This role serves as a quality representative within their area of expertise and supports quality assurance activities related to documentation control, change management, and sterilization processing to ensure all Boston Scientific processing requirements are met prior to QA approval.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. 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.

Your responsibilities will include:
Coordinate the review and revision of documentation submitted through change requests in accordance with internal and regulatory policies and procedures.
Prioritize weekly document processing activities to meet business and compliance timelines.
Copy, distribute, and maintain controlled documents in accordance with company procedures. Review final documentation changes, identify potential issues, and partner with stakeholders to resolve discrepancies.
Store and maintain quality records, policies, and procedures to ensure ongoing compliance with internal requirements.
Utilize imaging and electronic archiving systems to maintain accurate document records.
Process change notices through all applicable stages, including creation, submission review, implementation, and document issuance, ensuring appropriate distribution.
Assist in gathering change management metrics and preparing reports as required.
Represent the site in Global Communities of Practice and participate in associated projects as needed.
Process site nonconformances related to document and records management sub-processes.
Interpret and implement corporate documentation requirements to support local documentation needs.
Provide documentation control and change management support across site functions.
Partner with engineers to ensure documentation accuracy and adherence to good documentation practices.
Review and approve sterilization batch records to confirm all processing parameters meet Boston Scientific specifications.
Support the maintenance of policies and procedures related to sterilization processes and batch record approval.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality system requirements.

Qualifications:

Required qualifications:

Minimum of a bachelor's degree or equivalent experience in quality, engineering, science, or a related field.
Minimum of 1 year's experience in quality assurance, document control, records management, or a regulated manufacturing environment.
Working knowledge of quality systems and regulatory requirements, preferably within a medical device or similarly regulated industry.
Ability to interpret procedures, specifications, and regulatory documentation.
Strong attention to detail with the ability to manage multiple priorities in a…