Senior Quality Assurance Engineer

Additional Location(s): US-MA-Marlborough; 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: A global position in Post Market Quality Assurance offering exposure to all Boston Scientific products and business units. Opportunity to restore and solidify government-regulator and physician-customer confidence in our products, at a time when a recent adverse event involving Boston Scientific product(s) may have inspired doubt.

A Quality Assurance Engineer in Post Market Communications will prepare written product performance responses of high complexity to customers including government regulatory agencies, notified bodies, physicians, patients, sales representatives, and internal employees to promote or restore confidence in the quality and reliability of Boston Scientific products and services.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

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

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

Your responsibilities will include:

• Prepares/drafts timely responses to complaint related product performance requests from global regulators and physician-customers incorporating information from subject matter experts, approved product labeling, and quality records.
• Develops a comprehensive response strategy and seeks cross-functional subject matter experts to secure required technical and clinical information.
• Coordinates response reviews/approvals with subject matter experts and management.
• Delivers final response to government-regulator and physician-customer ensuring accuracy, readability, and consistency.

• Prepares and presents request metrics to management, seeking opportunities to reduce requests from global regulators by understanding emerging patterns/trends in requests.
• May review/edit draft communications prepared by others that are intended for external audiences (e.g., field action letters, audit responses, regulatory reports, etc.).
• Mentors Complaint Management Center in formulating product performance communication strategies and messages, including the development of template responses.

• Provides input for process improvements, and initiates/supports continuous improvement projects at a departmental and global post market/quality level.

Required qualifications:

• Bachelor’s degree + 5 years of industry experience [Master’s degree + 3 years].
• Medical device/regulated industry experience.
• Strong communication, writing, editing, and presentation skills. 

Preferred qualifications:

• Bachelor’s degree is preferred in a science / health/ engineering.
• Familiarity with interventional cardiology and peripheral vascular intervention medical devices preferred; knowledge with endoscopy and/or urology medical devices are also an asset.
• Experience with government-regulators and physician-customers communications. 
• Understanding of medical device reporting regulations and requirements.
• Complaint handling and Quality System processes experience.
• Strong analytical and problem-solving skills.
• PC literacy in word processing, spreadsheets, presentation applications, database management, and dashboards (Microsoft O365).
• Project management experience.
• Experience working with GenAI technology and BOTs.

Requisition ID: 623688 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

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.