Boston Scientific Gruppe
Supplier Quality Engineer II - Software
Boston Scientific Gruppe, Arden Hills, Minnesota, United States,
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. As a Supplier Quality Engineer II, you play a critical role in ensuring the safety, reliability, and compliance of sourced software used as a medical device (SaMD) or in medical devices (SiMD). You collaborate with suppliers, internal teams, and regulatory bodies to maintain high-quality standards throughout the product lifecycle to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer II will support sourcing and quality systems by participating in global communities of practice and value improvement projects.Your responsibilities include:Evaluate and select suppliers based on their capabilities, quality systems, and adherence to industry standardsEstablish strong relationships with suppliers, fostering open communication and collaborationAssess supplier capabilities through direct on-site visits and technical discussions. Coordinate the evaluation of proposed changes at suppliersEvaluate 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 documentationCollaborate with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documentsIdentify and advise management on potential improvements to quality systems and processes in the companyChampion 100% compliance to company policies and SOP’sWork closely with software development teams, quality assurance, regulatory affairs, and other stakeholdersParticipate in design reviews, risk assessments, and project meetingsDrive continuous improvement initiatives within global supply chainAnalyze data, track key performance indicators, and identify areas for enhancementImplement corrective and preventive actions to address quality gapsRequired 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 sourcingExperience in software quality assurance, supplier management, or regulatory compliance within the medical device industryCertification in quality management (e.g., ASQ Certified Quality Engineer) is advantageousProficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations)Strong analytical skills, attention to detail, and problem-solving abilitiesExcellent communication and interpersonal skillsDomestic and international travel up to 20%Requisition ID:
593454
#J-18808-Ljbffr
The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. As a Supplier Quality Engineer II, you play a critical role in ensuring the safety, reliability, and compliance of sourced software used as a medical device (SaMD) or in medical devices (SiMD). You collaborate with suppliers, internal teams, and regulatory bodies to maintain high-quality standards throughout the product lifecycle to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer II will support sourcing and quality systems by participating in global communities of practice and value improvement projects.Your responsibilities include:Evaluate and select suppliers based on their capabilities, quality systems, and adherence to industry standardsEstablish strong relationships with suppliers, fostering open communication and collaborationAssess supplier capabilities through direct on-site visits and technical discussions. Coordinate the evaluation of proposed changes at suppliersEvaluate 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 documentationCollaborate with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documentsIdentify and advise management on potential improvements to quality systems and processes in the companyChampion 100% compliance to company policies and SOP’sWork closely with software development teams, quality assurance, regulatory affairs, and other stakeholdersParticipate in design reviews, risk assessments, and project meetingsDrive continuous improvement initiatives within global supply chainAnalyze data, track key performance indicators, and identify areas for enhancementImplement corrective and preventive actions to address quality gapsRequired 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 sourcingExperience in software quality assurance, supplier management, or regulatory compliance within the medical device industryCertification in quality management (e.g., ASQ Certified Quality Engineer) is advantageousProficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations)Strong analytical skills, attention to detail, and problem-solving abilitiesExcellent communication and interpersonal skillsDomestic and international travel up to 20%Requisition ID:
593454
#J-18808-Ljbffr