Director of Quality Systems, Design Control and Acquisition Integration

Boston Scientific
Arden Hills, MN, US
Full-time

Additional Location(s) : US-MN-Maple Grove; US-MA-Marlborough

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 Director Quality Systems, Design Control and Acquisition Integration processes, is a unique opportunity for a strong leader on a high-performing, cross-functional / divisional / regional, team with varying responsibilities.

This Director will lead teams responsible for Global Design Control & Risk Management, Global Training & HR, Global Process Acceptance Activities and Controls & Process Validation, and Global Acquisition Quality System Integration processes.

This role will report to VP Quality Systems & Post Market and work in partnership with QA VPs, Site, Region & Divisional QA Directors and Global Operations leaders.

This Director will partner closely with the VP Global Supply Chain Acquisition Integration and team.

Your Responsibilities will include :

  • Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team.
  • Recruit, coach and develop organizational talent.
  • Develop and implement quality strategies; seeks innovative approaches to attaining quality goals.
  • Lead quality team on process development / improvement projects of major magnitude and global scope.
  • Builds cross functional strategic partnerships to further departmental and organizational objectives.
  • Ensure that systems, processes, and staffing are designed and implemented to maintain a suitable, adequate, and effective quality system.
  • Foster collaboration and partnership with Site, Region & Divisional Quality, Divisional R&D, Global Operations and other stakeholders that ensures compliance and drives continuous improvement in Quality System processes.
  • Key Quality voice of influence on projects, related to design controls, risk management, usability, reliability, and product performance.
  • Collaborates with Divisional Quality and cross-functional partners, develops successful integration strategies, and ensures that Quality Systems integration is supported.
  • Creates & quickly builds strong, collaborative relationships with acquisition company leaders.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Creates an entrepreneurial environment that keeps the organization's vision and values at the forefront of decision making and action.
  • Demonstrates effective change leadership.
  • Directly interface with internal and external audit activities.

Required Qualifications :

  • Minimum of a Bachelor’s Degree
  • Minimum of 10 years of related functional experience within Quality
  • Minimum of 5 years of previous management experience
  • Demonstrated ability to lead effectively across a broad and diverse body of work / functions / sites.
  • Regulatory compliance experience in the areas of medical devices

Preferred Qualifications :

  • Advanced degree preferred
  • Prior R&D, Design Assurance, Product and / or Process Development, and Risk Management experience preferred
  • Experience with acquisitions and quality system deliverables post-close
  • 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
  • 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 : 593556

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’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.

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