Boston Scientific Supplier Quality Engineer II - Software 

United States, Minnesota, Arden Hills 

410525487

Your responsibilities include:

• Evaluate and select suppliers based on their capabilities, quality systems, and adherence to industry standards
• Establish strong relationships with suppliers, fostering open communication and collaboration
• Assess supplier capabilities through direct on-site visits and technical discussions. Coordinate the evaluation of proposed changes at suppliers
• Evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation
• Collaborate with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents
• Identify and advise management on potential improvements to quality systems and processes in the company
• Champion 100% compliance to company policies and SOP’s
• Work closely with software development teams, quality assurance, regulatory affairs, and other stakeholders
• Participate in design reviews, risk assessments, and project meetings
• Drive continuous improvement initiatives within global supply chain
• Analyze data, track key performance indicators, and identify areas for enhancement
• Implement corrective and preventive actions to address quality gaps

Required Qualifications:

• Bachelor’s degree in engineering or a related technical field.
• Minimum of 2 years of experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.

Preferred Qualifications:

• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing
• Experience in software quality assurance, supplier management, or regulatory compliance within the medical device industry
• Certification in quality management (e.g., ASQ Certified Quality Engineer) is advantageous
• Proficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations)
• Strong analytical skills, attention to detail, and problem-solving abilities
• Excellent communication and interpersonal skills
• Domestic and international travel up to 20%

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.