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Director, Post Market Quality-IC Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

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

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.

Director, Post Market Quality-IC 

 

About This Role:

 

This is an exciting opportunity to lead the quality team supporting the IC division in Boston Scientific. You will work with your Quality, R&D, Regulatory, Manufacturing, Marketing, and commercial peers in developing current and future Product Performance improvement plans through leadership of the complaint investigation and field performance trending teams with oversight to the broader complaint management of IC.  You will be located on the Arden Hills or Maple Grove site and expected to provide support to other sites as required.  Organizational strategy of multiple lab operations and product investigation site locations with indirect reporting relationships and complaint management center partnership.  Influence over aligned execution of regulatory and CMC interactions related to complaints.  Leads statistical and data analytical oversight of performance, complaint management, reporting, and technical failure analysis.  Accountability for engineering recreation, media analysis, and adverse patient impact product investigation with medical staff and customers to determine cause of adverse event. You will also play a lead role in the development and execution of the ‘On Market Support Process’ for new and existing products.

 

Lead a divisional quality team with the following key responsibilities: 

  • Monitor post market performance of the IC commercial products and make recommendations to improve patient and customer outcomes
  • Champions and provides sponsorship of global and divisional complaint initiatives.
  • Owns the Complaint Review Board and associated Data Analysis
  • Partners with CMC and Design Assurance on Investigations and optimization of Complaint process and reducing overall IC complaints. 
  • Work collaboratively with the IC Quality Leadership team on Predictable Product Performance strategies.

 

The Director is responsible to:  Ensure product safety, reliability and high quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product life-cycle.  Understands and applies quality engineering principles to product complaint investigations, trending/data analytics and complaint reduction, to support an effective overall quality system. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Assure continuous improvement in product performance by incorporating learnings into new product development. Employ lean methodologies to improve the efficiency of the Quality System.

 

This role is open to considering candidates local to Arden Hill, MN as well as remote locations for qualified candidates

 

Your Responsibilities Will Include:

  • Will provide overall leadership to the team in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports and drive those practices throughout their organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Direct and control the activities and budget.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
  • 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.
  • Keeps the organization's vision and values 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, EEO regulations, etc.).
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.

 

What we’re looking for in you:
Minimum Qualifications:

  • Bachelor's degree plus 9+ years of related functional and leadership experience within the Quality space
  • 5+ years of direct managerial experience leading large and diverse teams across a highly matrixed organization
  • Ability to successfully manage and execute multiple, large scale projects using established project management tools and processes
  • Familiarity and experience with large scale Quality systems and methods that support product and customer needs 
  • Must have demonstrated leadership, influencing, and negotiation skills
  • Demonstrated capability in collaborating and partnering within a complex global supply chain environment
  • High degree of integrity, professionalism, and ability to establish credibility
  • Strong sense of urgency and commitment to execution
  • 5% travel required

 

Preferred Qualifications:

  • Advanced degree
  • Degree in Engineering
  • Medical Device Industry experience 
  • Executive presence, comfortable presenting and collaborating with Senior Leaders as a Business Advisor
  • Lean business/VIP experience 
  • Engineering or manufacturing background with ability to understand technical models
     

 

Requisition ID: 531916

 

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 is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-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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