Senior Quality Manager

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: The Senior Quality Manager will ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system.  The Senior Quality Manager will work with their group to ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Exceed customer expectations by responding to field events in a professional and timely manner.  Minimize the number of field events through effective analysis of returned products, corrective actions and timely investigation and response to field events. Communications with regulatory authorities. Reduce costs by employing Quality/Reliability System Processes that result in the development of efficient test and inspection plans, improved yields, and minimized scrap.

Your responsibilities will include: 

• Recruits, coaches and develops organizational talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Creates 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 and values at the forefront of decision making and action.
• Demonstrates effective change leadership and acts as an effective leader in supporting quality disciplines, decisions, and practices. 
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes Post Market Compliance programs, policies, and processes by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes, projects or operational plans and schedules in order to achieve department objectives.
• Manages department headcount budget to ensure effective resource planning, including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management.
• Develops, monitors and appropriately adjusts the annual budget for department(s) including determining appropriate staff levels, schedules and resources
• Defines best approaches and statistical techniques to product performance during launch, sustainment, and EOL 
• Defines and leads strategy advancement of technical insight and product performance improvement 
• Provide oversight to work done offsite and by 3rd party vendors. 
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement. 
• Develop and facilitate training and training support for the Post Market Surveillance organization. 
• Apply sound, systematic problem-solving methodologies cross-functionally when identifying, prioritizing, communicating, and resolving quality issues. 

Required qualification:

• Bachelor's degree in in a related field including Engineering, Life Sciences, Medical/Clinical or the equivalent combination of education and work experience
• Minimum of 5 years of related quality management experience
• Minimum of 2 years direct or indirect leadership experience
• Substantial working knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971

Preferred qualifications:

• Demonstrated experience building effective organizations and leveraging teams to accomplish objectives
• Experience with operational Continuous Improvement initiatives
• Strong technical writing skills and effective communication skills
• Advanced knowledge of quality principles including risk management practices

Requisition ID: 599737 

Minimum Salary: $ 122100 

Maximum Salary: $ 232000 

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 identify, 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.