Quality Engineer I at Boston Scientific in Arden Hills, MN

Summary: Boston Scientific is a global medical technology leader recognized for its innovative solutions in healthcare. The Quality Engineer I will develop and maintain quality engineering methodologies and practices to meet regulatory requirements and support manufacturing excellence.

Responsibilities:
- Develop an understanding of product quality plans, specifications, documentation and quality systems through training and collaboration with cross-functional teams
- Lead the implementation of quality assurance, process controls and CAPA systems designed to meet or exceed internal and external requirements
- Serve as an effective team member or project lead while supporting quality disciplines, decisions and best practices
- Own manufacturing processes and operator certification activities to ensure compliance with quality standards
- Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues using quality tools and established procedures
- Support the development and execution of streamlined business systems that effectively identify and resolve quality issues
- Identify manufacturing process defects, including scrap, nonconforming material and customer complaints, by dispositioning nonconforming material, assisting with root cause investigations and supporting corrective and preventive actions
- Partner with process owners to establish product containment, product disposition and release criteria when quality issues arise
- Perform final Process Monitor Release activities for products prior to distribution

Required Qualifications:
- Bachelor's degree in Engineering or a related technical discipline
- Knowledge of basic quality systems and good documentation practices

Preferred Qualifications:
- Experience managing multiple engineering projects across disciplines, including software, hardware, labeling or RTV
- Experience supporting manufacturing in the medical device industry; neuromodulation experience is preferred
- Familiarity with product and component documentation, inspection and testing, Manufacturing Execution Systems (MES) and Windchill/PLM
- Experience serving as a process owner
- Experience working with cross-functional teams and driving projects to successful completion
- Experience collaborating with Manufacturing Engineering, Post Market Complaints, CAPA, Risk Management, Supplier Quality and Process Engineering
- Strong presentation skills with the ability to communicate manufacturing performance, quality metrics and technical issues to peers and senior leadership
- Boston Scientific experience

Required Skills: Quality engineering methodologies, Quality systems, Quality assurance, Process controls, CAPA systems, Manufacturing process compliance, Systematic problem-solving methodologies, Root cause investigations, Corrective and preventive actions, Manufacturing Execution Systems (MES), Windchill/PLM, Process ownership, Medical device manufacturing, Neuromodulation, documentation practices, Project management

Benefits: Access to the latest tools, information and training, Help you in advancing your skills and career, Supported in progressing – whatever your ambitions