Quality Systems Engineer II (Remote)

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:
Join our collaborative team with global exposure and impact within a flexible work environment! The Quality Systems Engineer II will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within the Corporate Audit Support function and throughout the Boston Scientific network. Support the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulations.

This is a US based remote position.

Your responsibilities will include:

• Global Corporate Audit Support including monitoring audits and coordinating audit requests
• Ensure external Audit Readiness at Corporate site and across the Boston Scientific network
• Interface with Global Quality process and sub-process owners, cross-functional subject matter experts to ensure audit readiness
• Identify and communicate inspection and audit data, trends, and metrics across the organization
• Post audit support and response to external auditing organizations
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Advise on potential improvements or enhancement to quality systems and processes in the company
• Present and participate in External Audit Community of Practice, a forum for sharing best practices for planning, execution, and follow-up for external audits

Required qualifications:

• Bachelor’s degree and 2 years of related medical device experience or and equivalent combination of education and work experience
• Working knowledge of applicable regulations and standards, including EU Medical Device Regulation, ISO 13485, MDSAP, 21 CFR.
• Proficiency with Microsoft Office suite
• Demonstrated ability to apply continuous improvement principles in the development of the quality system
• Audit support experience
• Ability to adjust work schedule to accommodate a global audit schedule that spans time zones
• Ability to travel 10%

Preferred qualifications:

• Strong communication and presentation skills with the ability to clearly present complex data using data visualization
• Ability to develop effective, positive interpersonal relationships
• Audit experience (front room / back room / auditing)
• Driven, energetic, self-assured professional with high personal integrity
• Ability to coordinate and lead groups of people towards a common goal
• Proactive, work independently, and be a contributing member of a highly visible team
• Website/SharePoint development experience
• Experience driving continuous improvement / value improvement projects
• Experience writing and implementing quality system procedures
  

#LI-Remote

Requisition ID: 558259

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.