Senior Quality Specialist

Posted 23 Days Ago
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Arden Hills, MN, USA
In-Office
72K-136K Annually
Senior level
Healthtech
The Role
The Senior Quality Specialist leads quality integration initiatives for medical device acquisitions, ensuring compliance with quality system requirements and collaborating with cross-functional teams.
Summary Generated by Built In

Additional Location(s):  N/A; Canada-ON-Mississauga; Costa Rica-Coyol; Costa Rica-Heredia; US-MA-Marlborough; 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:

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 Senior Quality Specialist will be a member of the high-performing EP/CRM Quality Acquisition Integration Team, leading and supporting quality integration initiatives. This individual will serve as a key contributor in determining integration strategies related to the Boston Scientific Quality System sub-process, Document Control. This role will collaborate closely with team members supporting Records Control and Data Control, as well as broader Quality System integration activities. Success in this role will require strong cross-functional collaboration across integration teams and acquired entity personnel to achieve optimal business and compliance outcomes.

 

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Arden Hills, MN at least three 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:

  • Assess document control processes and systems at acquired entities and recommend integration strategies aligned with quality system requirements, regulatory expectations, and business priorities.
  • Lead and support product integration activities by defining and executing strategies for document migration and integration into Windchill.
  • Support acquired entity document control processes, as needed, to ensure business continuity and effective integration change management.
  • Implement Boston Scientific document control processes at acquired entities through hybridization and progression to Boston Scientific Quality System processes and procedures.
  • Support Records Control and Data Control integration efforts as needed, including leading implementation of Project Tracking Plan documentation.
  • Advise integration leadership on opportunities to enhance compliance and improve Quality System processes and controls at acquired entities.
  • Conduct training for acquired entity personnel on Boston Scientific document control processes and systems.
  • Support change requests and change notices across the EP/CRM Quality Integration Team, as needed.

 

Required qualifications:

  • Minimum Bachelor's degree in a related discipline and relevant 2 years experience within medical device quality or a related discipline.
  • Strong understanding of medical device Quality System directives, regulations, and standards.
  • Proven experience working in regulated industries, including FDA, ISO standards, EU MDR, and ISO 13485 requirements.
  • Strong subject matter expertise and working knowledge of the Windchill application.
  • Proven experience with additional PDM/PLM systems such as Grand Avenue, MasterControl, ETQ, or similar platforms.
  • Proven experience integrating acquired entities into the Boston Scientific Quality System.
  • Demonstrated ability to collaborate effectively within a team environment.
  • Ability to travel as required, estimated at 10%.

 

Preferred qualifications:

  • Project management knowledge and/or experience.
  • Strong analytical, problem-solving, and communication skills.
  • High degree of integrity, professionalism, and ability to effectively influence others.

Requisition ID: 628184

Minimum Salary: $71500 

Maximum Salary: $135800 


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.

Skills Required

  • Minimum Bachelor's degree in a related discipline
  • Relevant 2 years experience within medical device quality or a related discipline
  • Strong understanding of medical device Quality System directives, regulations, and standards
  • Proven experience working in regulated industries, including FDA, ISO standards, EU MDR, and ISO 13485
  • Strong subject matter expertise and working knowledge of the Windchill application
  • Proven experience with additional PDM/PLM systems such as Grand Avenue, MasterControl, ETQ, or similar platforms
  • Proven experience integrating acquired entities into the Boston Scientific Quality System
  • Demonstrated ability to collaborate effectively within a team environment

Boston Scientific Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.

  • Healthcare Strength Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
  • Retirement Support Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
  • Leave & Time Off Breadth Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.

Boston Scientific Insights

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The Company
HQ: Marlborough, MA
52,374 Employees
Year Founded: 1979

What We Do

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 40 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 health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.

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