Senior Quality Engineer

Additional Locations:  N/A; US-MN-Arden Hills

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: The Senior Quality Systems Engineer will provide engineering support within the business development space focused on product development, remediation, and distribution of acquired products. The engineer will serve as a Global Quality representative leading awareness, visibility, and communication of quality initiatives to support global quality goals, priorities, and compliance in the new business development space. The engineer will act as a primary point of contact between an acquisition and the global Business Development community.

Your responsibilities will include:     

• Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required.
• Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required.
• Applies technical quality engineering principles and systematic problem-solving methodologies to acquisition products or sites.
• Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
• Maintains and enhances cross-functional team relationships within divisions, manufacturing plants, distribution centers, and global BSC network.
• Advises management on potential improvements or enhancement to quality systems and processes in the company. 
• Assists in identifying and developing tools that facilitate BEST4 processes
• Potential global and US travel up to 40%.

Required qualifications: 

• Bachelor's degree in Science, Health, or Engineering 
• Minimum of 4 years of related work experience in the medical device regulated industry.
• Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485:2016, MDD, AIMD, AIMD, CMDR, RDC, JPAL, and MDSAP.

Preferred qualifications: 

• Design Quality Assurance experience.
• High energy problem solver capable of driving items to closure.
• Experience within BSC quality systems.
• Strong presentation & communication skills.
• Computer skills required including Excel, Word, and PowerPoint.
• Potential global and US travel up to 40%.
• > 3 years of experience working on acquisitions.
• Project Management Experience
• Experience working with across functions such as Operations, Regulatory, Research and Development, Clinical, and Quality.
   

Requisition ID: 563470

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!