Careers in MedTech

Job Title

Quality Engineer II


Boston Scientific


The CIS Quality Engineer II is an active participant within the MedSurg Complaint Investigation Site (CIS) and Data Reporting/Trending.  This role is responsible for managing the customer complaint failure analysis process for assigned product families; coordinating additional investigation with Business Unit Quality and/or the Supplied Finished Medical Device Manufacturer (SFMD); monitoring trending of product performance data and providing interpretive summaries of results; ensuring compliance with policy, procedures, and regulations applicable to Post Market Surveillance complaint handling, and working with BU Quality and SFMD partners to manage CAPA issues associated with complaints. Identify & implement Post Market Monitoring workstream improvements to increase the effectiveness, integrity, and/or timely management of complaint data monitoring, trending and reporting.  Provide subject matter expertise to crossfunctional personnel involved in complaint related processes and workstreams, including Complaint Review Board and Management Review Board.

Your responsibilities include:

  • Sustain product complaint investigation activities for the Complaint Investigation Site (CIS) for assigned product families.
  • Ability to work independently while maintaining compliance in a fast-paced, dynamic setting.
  • Apply engineering principles to the analysis of complaint medical devices.
  • Interface with intra/inter-site personnel to facilitate timely analysis of customer complaints and/or returned product.
  • Manage failure investigations including probable cause determinations with thorough, accurate, and timely documentation of findings.
  • Work closely with BSC Design Assurance/Sustaining Engineering on complaint product evaluation and provide detailed analysis of results as well as identify and recommend actions to cross functional teams for resolving device issues.
  • Work with Sourced Finished Medical Device (SFMD) partners to drive investigation closure.
  • Assist SFMD partners to conduct on-site failure investigations and visits as needed.
  • Participate in the development of protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company’s quality program.
  • Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency or develop new analytical methods and techniques.
  • Promote Good Laboratory Practices and comply with site safety and health hazard requirements when working in the lab and when working with lab personnel.
  • Become proficient in the use and maintenance of applicable equipment and/or tools.
  • Prepare for and participate in complaint Signal Escalation Review & Complaint Review Board and present data when applicable.
  • Support internal/external audits, which may include auditor facing activities.
  • Provide technical training and support of junior engineers.
  • Partner with BU Quality, Complaint Investigation Sites (CIS), Complaint Management Centers (CMCs) to ensure business data reporting requirements are met.
  • Ensure technical, reporting and analytical expertise in reviewing trends of product quality complaints.
  • Apply and improve existing statistical methodologies to trend/monitor product/process performance.
  • Prepare for and participate in the complaint signal escalation process (ESE/SER/SEF) in support of monthly and quarterly report out forums (CRB/QMR).


What we’re looking for in you:

  • BS/BA in Engineering and/or Science Related discipline.
  • 3-5 years in Quality role.
  • 1+ years in the medical device industry OR solid background in QSR and MDD Quality System requirements.
  • Understanding of data trending, product performance monitoring and application of statistical methodologies to analyze/interpret data.
  • Skills in Excel, and PowerPoint to query, trend, analyze, interpret, and present data.
  • Skills in the utilization of relational databases, SQL, Visual Basic and Power BI (a plus)
  • Understanding of regulatory requirement relating to the medical device industry.
  • Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio).
  • This position is in an office environment, with interaction with laboratories, BSC plants and external suppliers.
  • Able to communicate at all organizational levels both within BSC and with outside companies.
  • Able to work well in a team environment with peer group.
  • Travel may be required 5-15%
October 5, 2021
Marlborough, Masschusetts
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