New

Supplier Quality Engineer II - Software

Boston Scientific

4100 Hamline Avenue North (Show on map)
Jul 21, 2025
Recruiter: Spencer Gregory Hale Supplier Quality Engineer II - Software About the role: The External Operations organization at Boston Scientific is a passionate global 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 play an integral role in supporting the Cybersecurity Quality Master Plan (QMP) program by developing policies and procedures that address the dynamic and evolving regulatory requirements for cybersecurity. The Supplier Quality Engineering team is looking for high energy, driven, passionate people, looking to not just change jobs, but start an amazing career! Your responsibilities include: Supplier Management: 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. Quality System Champion: Support the Cybersecurity Quality Maser Plan (QMP) Program to drive key transformational BEST4 objectives Collaborate with divisional 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 SOPs. Cross-Functional Collaboration: Work closely with software development teams, quality assurance, regulatory affairs, and other stakeholders. Participate in design reviews, risk assessments, and project meetings. Continuous Improvement: 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. What we're looking for: Basic Qualifications Bachelor's degree in engineering or a related technical field Minimum of 3 years of experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. 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. Experience with problem solving quality tools and working with external suppliers Ability to communicate cross functionally with suppliers, team members and leadership Preferred Qualifications Certification in quality management (e.g., ASQ Certified Quality Engineer) is advantageous. Proficiency in relevant standards (e.g., ISO 13485, IEC 62304, IEC 81001-5-1, ANSI/AAMI SW96:2023, FDA regulations). Experience with cybersecurity for medical devices Strong analytical skills, attention to detail, and problem-solving abilities. Excellent communication and interpersonal skills. Domestic and international travel up to 20% Requisition ID:610450 Minimum Salary:$69500 Maximum Salary: $132000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.