Quality Engineer II

Additional Locations:  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 This Role:
This Quality Engineer II role will provide support for Molding & Men’s Health production operations at the Arden Hills site. An individual stepping into this role will help ensure delivery of the highest quality result to the customer, while supporting continuous improvement projects and quality initiatives. They will partner with a broader team to accomplish day-to-day floor support, proactive problem solving, NC dispositions, and NCEP/CAPA work. Additionally, this person will support value improvement projects, and Workstation Vulnerability Assessment efforts. In a fast-paced and dynamic environment, a Quality Engineer in this division would be a process owner for manufacturing line(s), working cross-functionally with their manufacturing engineering and production counterparts to achieve business goals. 

Your responsibilities will include:

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Collaborate with technicians and manufacturing engineers in assisting in identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material. May be responsible for working with process owners to bound product and document release criteria.
• Uses risk analysis tools, including but not limited to, hazard analyses, DFMEA, PFMEA, to evaluate and disposition product quality issues. 
• Perform process validation and verification activities, including test method validation, and generate/review related documentation.
• Identifies possible sources of manufacturing defects and devises methods to reduce process variation to reduce/eliminate the cause of defects.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Acts as team member in supporting quality disciplines, decisions, and practices.
• Participates in team decision making and displays team problem solving/communication skills.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Provide support and mentorship to area Quality Technicians 

Required qualifications:

• Bachelor’s degree in engineering or science related field
• 2+ years of experience in related roles
• Experience in a regulated medical device industry
• Prior experience with non-conforming material review process
• Basic understanding of test method validation methodologies

 
Preferred qualifications:

• Experience in molding and silicone related materials
• Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
• Experience in Validation, Statistical sampling and/or Root Cause Investigation
• Familiarity with product documentation, inspection and testing, and Manufacturing Execution
• Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.).

Requisition ID: 591337

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!