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Quality Engineer II Job

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Date: Apr 7, 2019

Location: Alpharetta, GA, US, 30009

Company: Boston Scientific

Additional Locations: (n/a)



Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.


Quality Engineer II


About the role:

The Quality Engineer II is responsible for providing Quality Engineering input to support Manufacturing, Manufacturing Engineering, Operations and Distribution activities. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Some support with new product development may be required as needed.


Your Responsibilities Will Include:

  • Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) leading or participating in efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions.  May be responsible for creating risk analyses and FMEAs.
  • Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
  • Owns and drives Nonconforming Event and Correction and Preventive Action investigations.
  • Supports continuous improvement activities, NCEPs, CAPA and Lean initiatives.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support internal and external regulatory audits.


What we’re looking for in you:


Minimum Qualifications

  • BS in an engineering/biomedical Engineering discipline with 2-5 years of technical experience
  • MS/ME with 0-2 years of technical experience
  • Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.
  • Experience in nonconforming material and CAPA methodologies/systems preferred.
  • Strong communication, presentation, facilitation, and project management skills.
  • Experience working in cross-functional teams and driving projects to completion
  • Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
  • High sense of urgency and commitment to execution
  • Applies continuous improvement principles in development of the quality system.
  • Driven, energetic, self-assured professional with high personal integrity
  • Knowledge of analytical techniques and statistical analysis
  • Ability to develop effective, positive interpersonal relationship


Preferred Qualifications

  • Medical device or Pharmaceutical experience
  • ASQ CQE certification
  • Six Sigma Certified Green or Black Belt


About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran


Requisition ID: 443228


Nearest Major Market: Alpharetta
Nearest Secondary Market: Atlanta

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