- Evaluate and select software suppliers based on their capabilities, quality systems, and adherence to industry standards.
- Establish strong relationships with suppliers, fostering open communication and collaboration.
- Conduct regular supplier audits to assess their quality management processes.
- Review and approve software-related documentation, including design specifications, test plans, and risk assessments.
- Ensure that software development processes comply with relevant standards (e.g., ISO 13485, IEC
- Monitor software change control processes and assess their impact on product quality.
- Participate in risk assessments related to software components.
- Identify potential risks associated with software design, development, and maintenance.
- Work with suppliers to mitigate risks and implement effective corrective actions.
- Collaborate with suppliers to improve their software development practices.
- Provide guidance on best practices, quality methodologies, and regulatory requirements.
- Facilitate training sessions for suppliers to enhance their understanding of medical device software quality.
- Ensure that software-related changes are properly documented and validated.
- Review and approve software validation protocols and reports.
- Support post-market surveillance activities related to software issues.
- 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 the software supply chain.
- Analyze data, track key performance indicators, and identify areas for enhancement.
- Implement corrective and preventive actions to address quality gaps.
- Bachelor's degree in biomedical engineering, computer science, software engineering, or a related field.
- Minimum of 4 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.
- 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.
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Software Supplier Quality Engineer III - Arden Hills, United States - Boston Scientific
Description
Hiring Manager: Matthew Paul Herlofsky
Recruiter: Spencer Gregory Hale
Software Supplier QA Engineer III
About the role:
As a Software Supplier QA Engineer, 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 Software Supplier QA Engineer will support sourcing and quality systems by participating in global communities of practice and value improvement projects. 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:
Quality Assurance:
Risk Management:
Supplier Development:
Product Lifecycle Support:
Cross-Functional Collaboration:
Continuous Improvement:
What we're looking for:
Basic Qualifications
Preferred Qualifications
Requisition ID:578994
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.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
