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Quality Engineer II
1 month ago
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 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 within the Electrophysiology (EP) division. 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.
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.
- 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:
- Bachelor’s degree in engineering or other related technical/scientific discipline
- Minimum of 1 year of experience in a highly regulated industry or Quality organization
Preferred qualifications:
- 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: 591946
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