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Senior Quality Engineer Job

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Date: Oct 23, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific




Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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 this role:

The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet BSC, customer and regulatory requirements.  This role will primarily be focused on providing quality engineering support to the new product development process.  In addition, this role will provide focused quality engineering support within operations production and quality systems.  This individual will also serve as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. 


This role will be in Maple Grove, Minnesota and will require the ability to work on-site.



Your responsibilities will include:

  • Support the development of new products and the transfer to production through cross-functional team collaboration, understanding technical requirements, supporting qualification, and ensuring adherence to the quality system and regulatory requirements.
  • Provide technical review and input throughout the process validation and verification process including gage repeatability and reproducibility studies.
  • Proactively investigate, identify, and implement best-in-class Quality Engineering practices and influence early implementation.
  • Provide leadership to the Quality Engineering team in championing departmental or cross-functional engineering initiatives.
  • Provide mentorship to support on-going manufacturing of products in identifing and implementing effective process control systems that meet or exceed internal and external requirements.
  • Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving complex and diverse quality issues.
  • Lead large scale corrective and preventive action (CAPA) projects using root cause analysis as well as identifying and implementing robust solutions.
  • Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
  • Represent Quality by supporting quality disciplines, decisions, and practices.
  • Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.



What we’re looking for in you:

Minimum Qualifications

  • Bachelor’s degree with an Engineering or Science background
  • 5+ years of experience in quality/operations or equivalent
  • Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements
  • Utilize strong communication skills through presentations, technical reports, daily updates and as necessary to meet the needs of the organization
  • Proficiency with Microsoft Office suite
  • Driven, energetic, self-assured professional with high personal integrity
  • Ability to develop effective, positive interpersonal relationships.

Preferred Qualifications

  • Experience in Medical Device Industry
  • American Society of Quality Certified Quality Engineer
  • Minitab proficiency







Requisition ID: 483789


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.


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Medical, CAPA, Manufacturing Engineer, Engineering, Healthcare, Quality, Management