Quality Engineer III

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 the role: Responsible for providing technical acumen and leadership to the IC Arden Hills Post Market Complaint Investigation Site (CIS) that directly supports complaint product investigations and signal escalations ranging from Single Use Devices to Capital Equipment and accessories.  It is intended this role focuses more on Capital Equipment but can vary based on the selected candidate. The team uses product performance data to investigate Post-Market field performance signals in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.  Key focus is on understanding and developing product and process specific improvements to increase rate of actionable outcomes of product investigations and improved use of Engineering Essentials and Problem-Solving Analytics to improve product performance in sustaining and future product lines.  Will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level.  Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes.  This role provides significant visibility across site and divisional leadership.  

 

At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week.

 

Relocation assistance is not available for this position at this time.

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

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 junior engineers and 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.
• 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.
• 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.
• 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:

• Bachelors Degree
• Minimum of 3 years of related experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.

 

Preferred qualifications:

• Experience in Medical Device industry 
• Familiarity with Post Market requirements and IT systems
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities 
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to succ