Quality Engineer II

Additional Locations: Costa Rica-Heredia

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles: 

Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role:

The Quality Engineer II will be primarily focused on the execution of Post Market Surveillance Reporting assessments, such as Market Experience Reports (MERs) and Periodic Safety Update Reports (PSURs), including but not limited to all associated design control and quality system deliverables related with execution. The Quality Engineer II identifies, analyzes, investigates, monitors, and documents trends at a product performance level for post marketing surveillance data. He/she/they will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level to ensure Electrophysiology (EP) products meet evolving standards in the European Union (EU) and globally. He/she/they will be responsible for identifying and helping execute continuous improvement projects related to product performance and the post market surveillance processes.  

Your responsibilities include:

• Analyzing customer complaints, compliance events, clinical data and post marketing surveillance data by examining patterns, trends and investigating when necessary.
• Contributing to relevant Communities of Practice regarding Post Market Surveillance activities with influence across multiple Boston Scientific divisions and departments.
• Leading investigation of potential and/or identified trends or data issues with cross-functional teams across division(s).  
• Initiating and executing continuous improvement projects to ensure Post Market Surveillance reports are completed with efficiency and compliance.
• Representing Post Market Surveillance for regulatory audits and supporting government agency inquiries, and questions. Provide guidance to ensure compliance to all relevant laws and regulations. 
• 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.

Minimum Qualifications:

• Bachelors Degree in Mechanical, Electrical, or Biomedical Engineering, or related discipline 
• 2+ years of related experience with design controls, post market and/or risk management 

Preferred Qualifications:

• Medical device experience strongly preferred
• Strong communication (oral and written) and presentation skills
• Strong experience with Microsoft Office Suite, specifically Excel
• Focus on detailed work with emphasis on accuracy and completeness. 
• Eager problem solver capable of driving items to closure and brainstorming areas for improvement. 

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Requisition ID: 612286

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.