Quality Engineer III

Additional Locations: Cartago

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 This role offers an individual 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 complete product analysis for investigations of field complaint allegations against Boston Scientific products. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively.

Your responsibilities will include:

· Applying mechanical and electrical engineering understanding to complete investigations and review/approve product analysis results to ensure field allegations are adequately addressed in a timely manner.

· Strong understanding of manufacturing processes and controls to aid in detection of potential manufacturing non-conformances leading to complaint allegations from the field.

· Partnering with manufacturing counterparts in Quality and Process Engineering teams to collaborate on investigations and correction/corrective actions related to device manufacturing. This will require strong communication skills with both manufacturing teams in Canada and Costa Rica.

· Own and support root cause analysis and initiation of correction and corrective actions through non-conformance evaluations when escalation to the correction and corrective action processes is a result of complaint trends in the field (ie. CAPA).

· Applying risk management and root cause analysis tools to determine the cause of emerging product issues and the impact these product non-conformities could have on patients and users.

· Applying data analysis skills to review multiple sources of post market data to support decision making.

· Focusing on continuous improvement by championing and fostering the execution of internal and global projects within the Post Market Quality department.

· Fostering a diverse 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.

· Support other activities within in the Complaint Investigation Site as needed, such as, brainstorming field action decisions, communicating product quality issues to management, etc.

· Adhere to all requirements of the Quality Management System. 

· Demonstrate company values, work with integrity, and be a supportive team member. 

· Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.  

Required qualifications: 

· Bachelor's Degree in Engineering

· 3-5 years of relevant work experience, including experience in manufacturing quality or process development

· Demonstrates critical thinking and problem-solving capabilities

· Strong communication skills, with the ability to establish impact and consequences

· Ability to collaborate and influence across multiple, cross-functional teams

Preferred qualifications: 

· Degree in Mechanical or Biomedical Engineering

· Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements

· Clinical knowledge of cardiology procedures

· Experience in the medical device industry

· Continuous improvement and Six Sigma experience

Requisition ID: 632208

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.