Boston Scientific · 12 hours ago
Quality Assurance Document Control Specialist
Coventry, RI
Full-time
Onsite
Entry Level
$47K/yr - $90K/yr
1+ years expBoston Scientific is a leader in medical science, dedicated to solving significant health industry challenges. The Quality Assurance Document Control Specialist is responsible for maintaining and improving documentation and records management quality systems in compliance with regulatory requirements, ensuring all processing requirements are met prior to QA approval.
Medical DeviceHealthcareHealth CareMedical
No H1B
Responsibilities
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
Qualification
Required
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 structured environment
Preferred
Experience supporting sterilization processes or batch record review
Familiarity with electronic document management systems and change control processes
Experience participating in cross-functional or global quality initiatives
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-02-09
WBJournal.com
2026-02-07
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