Senior Quality Director

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 Director role offers an exciting opportunity to lead a comprehensive site quality organization, encompassing design, operations, and supplier quality. This position is responsible for overseeing site quality management systems and ensuring compliance with relevant standards. The Senior Quality Director collaborates with key partners across divisional, corporate, and site teams, including Quality Assurance, R&D, Regulatory, Manufacturing, Medical Safety, Marketing, and commercial peers. Working closely with their team and partners, the Senior Quality Director ensures that systems, processes, and staffing are in place to maintain an effective quality system. They are committed to ensuring product safety, reliability, and quality through the strategic use of quality planning, risk analysis, statistical methods, and process controls throughout the product lifecycle, from design and manufacturing to post-market stages. 

Furthermore, the Senior Quality Director is instrumental in seamlessly integrating the site into the Boston Scientific Corporation (BSC) Quality Management System (QMS), ensuring alignment with corporate quality standards and practices.  In this role, he/she/they will foster and enable effective and flexible integration plans, methods and approaches, ensuring efficient and effective compliance throughout the integration. The Senior Quality Director will effectively engage, partner and influence both corporate and divisional entities to assure that BSC’s broader aims are met (business and quality).

The role will be primarily located in Carlsbad CA but will interact directly and frequently with broader divisional teams/sites. This is a hybrid position (in office minimum three days per week).

Your responsibilities include:

• Recruiting, coaching and developing organizational talent.
• Engaging with cross-functional partners and acquired teams/team members to enable collaborative solutions that result in broad wins.
• Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Creating an entrepreneurial environment.
• Providing direction and guidance to team members so they achieve individual, project and team goals.
• Keeping the organization's vision and values at the forefront of decision making and action.
• Demonstrating effective change leadership.
• Building strategic partnerships to further departmental and organizational objectives.
• Developing and executing organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitoring compliance with policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Making decisions regarding work processes or operational plans and schedules in order to achieve objectives.
• May serve as Quality System Management PRRC (Person Responsible for Regulatory Compliance) Representative (Article 15 of the Medical Device Regulation 2017/745), ensuring that conformity of devices are appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. (Article 15a).  Ensures that post-market surveillance obligations are complied with Article 10(10). (Article 15c) and that vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled (Article 15d).  Remains at the disposal of the EU Authorized Representative and shall suffer no disadvantage within the manufacturer's organization in relation to the proper fulfilment of his/her duties.

Required Qualifications:

• Minimum of a Bachelor's degree 
• Minimum of 10 years of Quality engineering experience in a medical device or regulated environment or similar related work experience 
• Minimum of 5 years of previous direct or indirect management experience 
• Demonstrated ability to lead effectively across a broad set of cross-functional partners/teams and diverse body of work/functions/sites.
• Ability to travel 25%

Preferred Qualifications:

• Advanced degree preferred
• Lean business/VIP experience
• Demonstrated ability to be an inclusive leader with proven experience collaborating with peers
• Demonstrated ability to influence and drive consensus across multiple parties in a highly matrixed organization
• Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
• Ability to be innovative and drive new perspectives based on industry standards and best practices
• High sense of urgency and commitment to execution
• Proven adaptability, comfortable with change and with a demonstrated ability to react and response to a fast-changing environment

Requisition ID: 615654 

Minimum Salary: $ 164800 

Maximum Salary: $ 313200 

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.