Quality Assurance Document Control Specialist

Boston Scientific • Coventry, RI

14d

About The Position

Your responsibilities will include: Coordinate the review and revision of documentation submitted through change requests in accordance with internal and regulatory policies and procedures. 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. Process site nonconformances related to document and records management sub-processes. Provide documentation control and change management support across site functions. Support the maintenance of policies and procedures related to sterilization processes and batch record approval.

Requirements

• 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.
• Familiarity with electronic document management systems and change control processes.

Nice To Haves

• Experience supporting sterilization processes or batch record review.
• Experience participating in cross-functional or global quality initiatives.

Responsibilities

• Coordinate the review and revision of documentation submitted through change requests in accordance with internal and regulatory policies and procedures.
• 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.
• Process site nonconformances related to document and records management sub-processes.
• Provide documentation control and change management support across site functions.
• Support the maintenance of policies and procedures related to sterilization processes and batch record approval.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level