Boston Scientific Quality Engineer 

United States, Minnesota, Arden Hills 

728318314

The Quality Engineer I develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The individual in this role also serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals, and priorities.

Your responsibilities will include:

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues

What we're looking for in you
Required Qualifications:

• Bachelor’s degree in engineering or a related discipline
• Knowledge of Quality Systems and good documentation practices
• One year of quality engineering experience in medical device or regulated industry

Preferred Qualifications:

• Demonstrated experience managing multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines
• Experience in medical device field in a manufacturing support role a plus
• Experience leading cross-functional teams and driving projects to completion
• Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, process engineering
• Knowledge of analytical techniques and statistical analysis
• Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate manufacturing performance and issues to peer and senior management audiences
• Experienced with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System (MES)
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.