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Quality Engineer II Job

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Date: Jul 12, 2019

Location: Minnetonka, MN, US, 55343

Company: Boston Scientific



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:

Responsilble for product investigations associated with complaints, including handling of physical product returns. Reviews product return information, investigations conclusions and coding to ensure the investigation is adequately documented and the most probable conclusion code was selected based on the analysis/testing conducted. Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system. Communicate and educate management, R&D, quality, marketing, sales organization and other departments, as well as external customers about product performance.  Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D, design quality and marketing organizations as part of the risk management and design input systems.



Your Responsibilities Will Include:

  • Perform testing, in a laboratory setting, on returned medical devices associated with customer complaints to determine the most probable cause of the complaint, while ensuring timely closure. Documenting the product investigation activities clearly and accurately.
  • Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
  • Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.
  • Completes assigned tasks to meet department goals and objectives, ensuring that investigations applicable to product complaints and related records within the Global Complaints Management System are robust, with insightful conclusions that support product performance improvements.
  • Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
  • Provides input for process improvement and helps develops tactical approaches to implement team strategies.
  • Provides coaching and mentoring to engineering and/or technical team personnel.



What We're Looking For In You:

Minimum Qualifications

  • BS degree in an Engineering discipline or related field of study with minimum 2 - 4 years related experience or MS degree in a related field of study with 0 - 2 years related experience
  • Advanced problem solving skills - proven ability to identify and solve problems
  • Experience working with Quality Systems Regulations
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies

Preferred Qualifications

  • Ability to analyze complex data sets using statistical and engineering tools and communicate results to broad range of audience
  • Ability to apply engineering essentials to quality investigations to drive to root cause understanding and effective solutions
  • Advanced Minitab, Excel or equivalent software system skills
  • Understanding of external regulations FDA CFR 820, ISO 13485
  • Familiarity with complaint handling processes




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: 448705


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, CAPA, Medical Technology, Engineering, Quality, Management, Healthcare, Customer Service