Senior Quality Manager, CDx Services

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: At Boston Scientific, the Senior Quality Manager, CDx Services is responsible for providing leadership, subject matter expertise, and process stewardship across the CDx Services business, ensuring that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. This role plays a critical part in shaping CDx Services strategy, ensuring compliance to quality and regulatory requirements (including reportability), and driving operational excellence. The Quality Manager will work with their group to ensure safety, reliability, and quality of cardiac reports, and related outputs, through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and production stages of the report build process. Exceed customer expectations by responding to post market feedback and field events in a professional and timely manner.  Minimize the number of field events through effective analysis of information/data, corrective actions and timely investigation and response to post market feedback and field events. Reduce costs by employing quality and reliable system processes that result in the development of efficient test and inspection plans, improved yields, and minimized rework.

The successful candidate will excel at building strong relationships, understanding the interdependencies across holistic CDx operations, and identifying future strategic capabilities. They will guide a diverse team, influence an assorted set of stakeholders, and serve as a trusted advisor in CDx Services quality matters. This role also includes managing and developing a team (4-8 direct reports) in the Auditing, Post Market, Quality Assurance and Process Quality function with the Service-based business.

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.

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

Your Responsibilities Include:

• Lead, coach, and develop team to build expertise, accountability, and long-term talent capability within the organization.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.  May supervise non-exempt employees.
• Keeps the organization's vision, values and objectives at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, Medicare, EEO regulations, etc.).
• Make decisions regarding work processes or operational plans and schedules to achieve department objectives.
• Develop, monitor, and appropriately adjust the annual budget for department(s), as necessary.
• Provides appropriate level of cross-functional and customer-oriented communication regarding the status of department and quality system operation, as well as product performance.
• Influence and collaborate with a diverse stakeholder base to adapt processes, represent the voice of quality, and drive adoption of best practices.
• Build and sustain networks across the overall CDx business group to ensure aligned processes and consistent execution.

Required Qualifications:

• Bachelor’s degree in engineering, or related technical/science-based field.
• Minimum of 8 years of experience in Quality or Operations roles within a regulated industry (medical device, pharmaceutical, or related).
• Strong knowledge of Quality Systems and regulatory requirements (ex: FDA, EU MDR, ISO 13485).
• Demonstrated experience with process ownership, CAPA management, and compliance leadership.
• Proven track record of leading cross-functional initiatives and influencing stakeholders at peer group and 1-up level.
• Demonstrated experience in people leadership, including managing, coaching, and developing teams.
• Minimal travel required.

Preferred Qualifications:

• Advanced degree (MS, MBA, or equivalent).
• Experience with complex systems within a regulated business.
• Knowledge of EKG arrhythmia and the adjudication of such.
• Strong strategic thinking capability with the ability to balance long-term vision with executional excellence.
• Experience supporting a wide range of employee groups.
• Ability to drive change in a matrixed organization.
• Willingness to drive and complete actions when situation arises.
• Excellent collaboration, communication, and interpersonal skills with the ability to work across locations.

Requisition ID: 619275 

Minimum Salary: $ 116300 

Maximum Salary: $ 221000 

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.