Quality Assurance Document Control Specialist

Additional Location(s):  N/A

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 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.

Requisition ID: 624593 

Minimum Salary: $ 47200 

Maximum Salary: $ 89700 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. 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 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.