Engineer II, QA

 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 WFH and onsite. You will have the opportunity to discuss details in the interview. 

About the Role:

Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system. Communicate and educate management, R&D, marketing, sales organization and other departments, as well as external customers about product performance.  Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing organizations as part of the risk management and design input systems.

Your Responsibilities Include:

• Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
• Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.
• Documents trend action by updating the trend report at appropriate levels and by performing a Health Risk Analysis.
• 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.

What We’re Looking For:

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
• English Level desired: 80-95%.
• Desired knowledge: ASQ certification (CQE, SSGB) desired, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.g. Gage R&R, DOE, process capability, problem solving methodologies, electrical technical knowledge.
• Experience on managing regulations and complaint MDR / MDV.
• At least 2 years of experience in similar position.
• Or an equivalent combination of education and experience

Requisition ID: 590571

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.