Quality Engineer II Job

 

 

 

 

 

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 This Role:

Provide Quality Engineering support to Maple Grove 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 production and manufacturing engineers for daily operations support, and with product development teams to ensure development of robust new products.  This position will also serve as a project lead to transition risk management deliverables for meeting the new European Union Medical Device Regulations.

 

 

Your Responsibilities Will Include:

  • Develop and updating risk management deliverables
  • Perform process validation and verification activities and review related documentation
  • Lead or participate in projects to identify root cause and implement corrective and preventive actions.
  • Responsible for understanding nonconformance scope, implementing product stops, and determining release criteria.  Responsible for investigating nonconformances and writing required documentation.
  • 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 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.
  • 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.

 

 

What We’re Looking For In You:

Minimum Qualifications

  • BS with 2 or more years of relevant experience, specifically working with risk management documentation such as d/pFMEAs
  • 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, and process engineering
  • Knowledge of analytical techniques, problem solving 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.

 

Requisition ID: 473229

 

Posted
01/07/2021
Salary Range
$62,000.00 - 92,000.00
per Year
Salary range estimated by
Location
Maple Grove, MN 55311, US