Quality Assurance Document Control Specialist

Quality Assurance Document Control Specialist

Onsite Location(s):
Coventry, RI, US, 02816

Additional Location(s): N/A

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 structured environment.

Preferred qualifications:

• 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.

Boston Scientific Corporation is an equal opportunity employer and offers affirmative action in hiring. The company is committed to ensuring a diverse, inclusive workplace. All personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to protected classes.

Applicants must provide proof of COVID‑19 vaccination status for certain U.S.‑based positions. This role is safety‑sensitive and requires a prohibited substance test.

Nearest Major Market: Providence

Nearest Secondary Market: Rhode Island

Job Segment: Document Control, Compliance, Quality Assurance, QA, Records Management, Administrative, Legal, Technology, Quality, Records