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Quality Engineer II Job

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Date: Sep 9, 2021

Location: Spencer, IN, US, 47460

Company: Boston Scientific

Additional Locations: (n/a)


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.


Quality Engineer II 

About the role:


The Quality Engineer develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serves as a Quality representative for quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provide focused quality engineering support in a manufacturing environment.


This role will be in Spencer, Indiana and will require the ability to work on-site.


Your responsibilities will include:

  • Provide direct support to on-going manufacturing of products by identifying and implementing effective process control systems that meet or exceed internal and external requirements.
  • 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.
  • Apply technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Lead 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.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
  • Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
  • 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:
Basic Qualifications

  • BS in relevant discipline (engineering/sciences, manufacturing, quality, business)
  • Demonstrated interpersonal skills with ability to work within a team environment
  • Strong written/verbal communication skills
  • Must be able to work independently under limited supervision


Preferred Qualifications

  • Experience in the medical device industry
  • Six Sigma problem solving methodologies
  • Training experience to FDA regulations or ISO standards




Requisition ID: 487636


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: Bloomington Indiana

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