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Corporate Clinical Quality Assurance Principal Specialist

Boston Scientific

Boston Scientific

Quality Assurance
Marlborough, MA, USA
Posted on Thursday, July 4, 2024

Additional Location(s): US-MN-Maple Grove; US-IN-Spencer; US-MA-Quincy; US-MN-Arden Hills; US-RI-Coventry

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 Corporate Clinical Quality Assurance (CQA) Principal Specialist will help manage Corporate CQA activities in line with strategies and goals set by Quality and Clinical management. Ensures clinical research activities conform to federal and international standards and BSC processes and expectations. This role will help drive the implementation of Quality Management-approved solutions to ensure compliance through effective, efficient, and sustainable processes.
Your responsibilities will include:

  • Work with Quality and Clinical Stewards and senior management to support maintenance of the Product Approval – Clinical Trial quality system subprocess including process improvements, maintenance of procedures to regulatory requirements, and addressing compliance risks.
  • Collaborate with Global Clinical Operations to ensure ongoing compliance of clinical research activities and operational efficiency through support of CAPAs, process improvement initiatives, and clinical systems.
  • Acts as a consultant relative to the interpretation of regulations and their impact on Clinical trial processes and implementation of new QS requirements.
  • Help identify key areas of regulatory risk and suggest potential resolutions as well as ways to improve compliance to regulations and BSC policies and procedures.
  • Partner with divisional/regional Clinical Quality teams to gather data for management reviews and maintenance of clinical quality dashboards.
  • Support analysis of Clinical metrics to identify opportunities for improvement.
  • Support internal and external audits of BSC, as needed.
  • Contribute as SME to the development and maintenance of BSC policies and procedures, as needed.
  • Lead project activities, as needed, under the direction of Quality Management. Develop project plans outlining work plans, timelines, roles, and resources.
  • Communicate status, risks, and resolutions to management on key initiatives.
  • Create relationships across the business that enable sharing of knowledge, best practices, and solutions that can be leveraged across Clinical.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Minimal travel

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

  • Bachelor’s degree in Life Sciences, Engineering, or related field
  • Minimum of 7 years of Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs experience
  • Medical device industry experience required
  • Working knowledge of FDA, ISO, EU MDR, and medical device industry quality requirements governing human subject research.

Preferred Qualifications:

  • Ability to work collaboratively with cross-functional and cross-divisional partners
  • Strong communication skills
  • Tableau experience a plus

Requisition ID: 586176

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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 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.