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Quality Engineer I Job

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Date: Jan 11, 2019

Location: Arden Hills, MN, US, 55112 Arden Hills, MN, US, 55112 Arden Hills, MN, US, 55112

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.

 

About the role

Provide Quality/Process Engineering support to Arden Hills commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives.  Partner with product development teams to provide quality engineering support and help ensure development of highest quality new products.  This position may also provide quality engineering support for acquisition work as necessary. This position requires interactions with multiple divisions and value streams across Boston Scientific.

 

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 implementing product stops & documenting release criteria.
  • Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members.  May be responsible for creating risk analyses and FMEAs.
  • Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
  • 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.
  • Will own and drive Nonconforming Event and Correction and Preventive Action investigations.
  • Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
  • Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.   Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
  • May be responsible for the final Process Monitor Release for products prior to distribution.

 

What we’re looking for in you:

Basic Qualifications

  • Bachelor’s degree with 0-2 years of relevant experience
  • Good written and verbal communication skills.
  • Must be able to work independently under limited supervision
  • Knowledge of basic Quality Systems and good documentation practices

 

Preferred Qualifications

  • Demonstrated experience managing multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines.
  • Experience in medical device field in a manufacturing support role a plus
  • Self-starter with the ability to identify improvement opportunities
  • Experience leading cross-functional teams and driving projects to completion.
  • Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, process engineering
  • Knowledge of analytical techniques and statistical analysis
  • Comfort speaking to groups of individuals.  Presentation skills that comfortably and concisely translate manufacturing performance and issues to peer and senior management audiences.
  • Proficient with Microsoft Office tools including Word, Excel, Powerpoint, and Outlook.
  • Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System (MES)
  • Bachelor’s Degree with engineering or science major

 

 

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: 441614

 


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