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Quality Engineer I Job

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Date: Sep 9, 2021

Location: Spencer, IN, US, 47460

Company: Boston Scientific

Additional Locations:

 

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 I
 
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)
  • Boston Scientific Experience
  • 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
  • Knowledge of Spanish language (or bilingual) to translate documents or interact with Spanish speaking product builders is a plus.

 

Requisition ID: 495577


Nearest Major Market: Bloomington Indiana

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