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Quality Engineer I Job

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Date: Sep 10, 2021

Location: Spencer, IN, US, 47460

Company: Boston Scientific

Location: Spencer, Indiana (US-IN), United States (US)
Additional Locations: (n/a)
Hiring Manager: Lauren Noelle Tauber
Recruiter: Spencer Gregory Hale

 

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)
  • 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

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

 

Requisition ID: 496121


Nearest Major Market: Bloomington Indiana

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