Senior Quality Specialist - Acquisitions & Integrations (AI)

Additional Location(s): US-MA-Marlborough; Canada-ON-Mississauga; Costa Rica-Coyol; Costa Rica-Heredia; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; Israel-Kadima; Israel-Yokneam; Puerto Rico-Dorado; US-CA-Irvine; US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove

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:

The Acquisitions & Integrations (AI) Senior Quality Specialist will primarily support the integration of Boston Scientific (BSC) Document and Records Control processes into acquired companies. The role will ensure that processes and systems align with established BSC and regulatory standards, and that appropriate quality system processes are defined, maintained, and consistently followed in support of corporate and site quality objectives. In addition, the role will support the development and maintenance of processes, procedures, tools, and templates to drive innovation, harmonization, and sustained compliance with the BSC Quality System and applicable regulations.

 Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is open to work in the following US based sites in Irvine, CA, Spencer, IN, Arden Hills, or Maple Grove, MN, Austin, TX or Marlborough, MA and requires being on-site at least three days per week. We will also consider candidates open to work out of the following global sites based in Canada, Costa Rica,  Ireland, Puerto Rico, and Israel locations.

Relocation assistance:

Relocation assistance is not available for this position at this time.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Assess Document and Records Control processes and systems at acquired companies and recommend integration strategies aligned with business and regulatory needs.
• Support product integration by defining and executing strategies for document migration and/or integration into Windchill.
• Implement BSC Document and Records Control processes at acquired entities through hybridization and eventual full adoption of BSC standard procedures.
• Provide quality system expertise and guidance to support integration activities and ensure audit readiness/ support and sustained compliance.
• Advise management on opportunities to enhance quality systems, processes, and controls.
• Deliver training and onboarding to acquired‑entity SMEs on BSC document and records control processes.
• Apply structured problem‑solving methodologies to identify, prioritize, and resolve quality and compliance issues.
• Promote harmonization and innovation across A&I through the development and continuous improvement of procedures, tools, and templates.

What we’re looking for in you:

Required qualifications

• Bachelor’s degree in a relevant field.
• Minimum 5 years of experience in Quality Systems.
• Minimum 2 years of hands‑on experience with PDM/ PLM systems, for example: Windchill (QMS, DMR, DHF document management, Parts and BOMs revisions)
• Experience working in a regulated industry.
• Working knowledge of ISO 13485, 21 CFR 820, EU MDR, and other applicable regulations and standards.
• Strong sense of urgency, attention to detail and demonstrated commitment to execution.
• Ability to collaborate effectively across multiple time zones.
• Willingness and ability to travel as required (30% - 50%)

Preferred qualifications

• Advanced degree.
• Medical device industry experience.
• Experience with Document and/or Records Control.
• Project management experience.
• Strong analytical, problem‑solving, and communication skills.
• Demonstrated inclusive leadership and collaboration skills.
• High degree of integrity, professionalism, and ability to influence without authority. 
• Experience in quality compliance and product Integration strategies in Acquisitions & Integrations (A&I)

Requisition ID: 625700 

Minimum Salary: $ 89200 

Maximum Salary: $ 169500 

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.