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Director, Quality Systems Integration Job

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Date: Jan 10, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Maple Grove



Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.


Director, Quality Systems Integration   


About the role:

Everyone in Boston Scientific is working toward one goal - transforming lives by tackling some of the most important medical device industry challenges.  Patient Care is at the center of everything that we do – and Quality Compliance and Patient Outcomes are critical aspects of ensuring that we deliver on our commitment to Patient Care. 

As the Director Quality Systems Acquisition Integration, you will be primarily responsible for successful integration of quality system deliverables of acquisitions, post-close, across all Divisions and Regions.

This role will report to VP Global Quality Systems and work in partnership with the QA VPs, Site, Region & Divisional QA Directors and Manufacturing & Supply Chain leaders.

The role will have dotted line to the VP Operations Acquisition Integrations and partner closely with that team.

The quality acquisition lead will have a permanent team of Quality System Integration SMEs plus the Acquisition Integration Steward reporting directly into this role. 

The quality acquisition leads for each individual acquisition will report dotted line into this role but continue to report directly into the relevant Multi-site VP for the duration of the Integration.


Your responsibilities include:

  • Creates & quickly builds strong, collaborative relationships with acquisition company leaders.
  • Creates and maintains relationships with Business Development organizations.
  • Develops integration strategies in conjunction with QA VPs and divisional partners to ensure successful integration.
  • Works closely with Global Ops Strategy team and the Divisional partners on due diligence hand-over as well as deal model assumptions.
  • Works closely with the VP Operations Acquisition Integrations and partner with that team.
  • Works closely with receiving sites and DCs to support and execute strategies to successfully transition into BSC Manufacturing and Supply Chain.
  • Coordinates and aligns strategies with Divisional Quality and Divisional and Global RA.
  • Responsibility for understanding compliance of the Acquired Companies Quality System to all applicable regulatory requirements – including ISO 13485, MDD/MDR, FDA QSR, Health Canada, ANVISA, TGA, NMPA and other international requirements as applicable.
  • Drives Quality Planning release and subsequent updates.
  • Focused on integration quality planning for Quality Systems, Manufacturing Controls, Supplier Management, Distribution Controls, Sterilization and Post Market Surveillance
  • Responsible for working with GRC & Divisional leads on completion of initial Quality System audit post-closure.
  • In partnership with the Divisional teams, responsible for assigning the Quality System Integration SMEs to the appropriate activities.
  • Facilitates connections & networking between acquisition employees & leaders and relevant BSC functions/regions/divisions as needed.
  • Ensures acquisition integration resourcing requirements and gaps are appropriately escalated through instant offence & integration resource planning & identification.
  • Collaborates with Divisional Quality and Regulatory functions to ensure that latest regulatory requirements are integrated into process and that Quality Systems integration is supported.
  • Works closely with IT and system SMEs to ensure quality systems and other IT systems are successfully and appropriately installed, implemented and/or integrated.
  • Working with the Quality Systems Integration Steward on the development of Quality System Integration best practices and playbooks.  Continually refining the quality and effectiveness of the processes.
  • Working on the development of the Quality System Integration competency within the broader Quality organization. 
  • Provides training, mentoring and consulting services to integration teams.
  • Regular reporting, tracking and metrics on progress to Senior Leadership Team(s).
  • Works with Divisional teams in ensuring all acquisition employees are aware of their responsibilities to patient safety and product quality and ensures processes in place to meet BSC training requirements.
  • Actively models the BSC core values and promotes the acceptance of these core values in acquisition leadership.
  • Fosters an inclusive workplace culture that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives.
  • Creates an environment that encourages: constructive feedback and coaching; understanding of individual career goals and aspirations; and proactive developmental support for all employees.


What we’re looking for in you:

  • Bachelor’s degree required; advanced degree an advantage
  • 10+ years of experience in Quality in the Med Device industry; five + years in a leadership role
  • Experience working with all applicable regulatory requirements – including ISO 13485, MDD/MDR, FDA QSR, Health Canada, ANVISA, TGA, NMPA and other international requirements as applicable
  • Experience in dealing with external regulatory bodies
  • Experience in leading complex integrations and/or transfers across geographies
  • Experience working with acquisitions and due diligence efforts preferable
  • High sense of urgency and commitment to execution
  • Demonstrated problem-solving capabilities
  • Strong business and financial acumen, with ability to quickly establish impact & consequences
  • Knowledge of business systems and information technology for managing complex manufacturing activities
  • Demonstrated capability in collaborating and influencing across a global, matrixed organization
  • Ability to make consequential decisions in a high-pressure environment, whilst bringing along stakeholders
  • Demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally
  • Promotes a high-performance, inclusive culture within a quality focused environment



About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran


Requisition ID: 441745


Nearest Major Market: Boston

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