Quality Engineer I

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About this role:

This Quality Engineer role offers an employee the opportunity to be part of the Electrophysiology Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to support analysis of investigations into field complaint allegations against Boston Scientific products within the electrophysiology division. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively, to drive actions to improve current & future product performance.

 

Your responsibilities will include:

• Analyzing customer complaints, events, and other post market surveillance data by examining the data for patterns and trends and investigating when necessary. 
• Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities.  May include NCEP & CAPA ownership.
• Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.  Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc.)
• Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements.
• Communicating product performance through 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.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations. 
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Communicating emerging product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Research and Development, Supplier Quality and Manufacturing
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 

Required Qualifications:

• Bachelor’s degree in engineering or other related technical/scientific discipline

 

Preferred Qualifications:

• Bachelor’s degree in Electrical Engineering
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
• Experience in Medical Device industry or a Quality organization
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Ability to collaborate and influence across multiple, cross-functional teams

• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities

 

 

 

 

 

Requisition ID: 605976 

Minimum Salary: $ 58200 

Maximum Salary: $ 110500 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual l