Sr. Global Software Quality Engineer
About The Position
Your responsibilities will include: Apply fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements. Collaborate with management to understand priorities and provide input on resource and time allocation. Provide full guidance on the acceptability of software quality and validation deliverables and lead the development and execution of validation strategies. Guide implementation of enterprise system solutions and device commercialization efforts through system planning, integration, and validation activities. Contribute to the development, review, and/or approval of SOPs and supporting work instructions. Deliver structured quality assurance activities and metrics to support efficient, cost-effective operations.
Requirements
- Bachelor's degree in science, engineering, or software discipline.
- Minimum of 6 years' experience in a related role, including at least 3 years' experience in software quality assurance and validation.
- Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304, and cGxP for medical devices.
- Strong understanding of quality system requirements and their interdependencies.
- Experience with Agile software development and validation methodologies.
- Experience supporting enterprise system validations (e.g., SAP) and/or digital health/SaMD products.
- Some knowledge of cybersecurity and security risk analysis.
- Familiarity with work management and testing tools (e.g., JIRA, qTest).
- Comfortable communicating and presenting to leadership.
- Strong verbal and written communication skills.
- Creative and innovative problem-solving skills.
- Proven ability to manage projects and deliverables through to completion.
- Experience working independently and collaboratively in cross-functional teams.
- Strong organizational skills with the ability to manage multiple priorities.
- Experience or knowledge of design controls, risk management, and labeling processes.
- Experience or knowledge of GenAI applications.
- Understanding of risk management per ISO 14971 and AI risk assessments per the EU AI Act.
- Experience with AI implementation and monitoring plans.
- Familiarity with CAPA, vendor controls, complaint handling, and external audits.
- Basic understanding of HIPAA, GDPR, and data security regulations.
- Experience or knowledge of digital platforms and development tools such as Salesforce, GitLab, Bitbucket, and JIRA.
Responsibilities
- Apply fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements.
- Collaborate with management to understand priorities and provide input on resource and time allocation.
- Provide full guidance on the acceptability of software quality and validation deliverables and lead the development and execution of validation strategies.
- Guide implementation of enterprise system solutions and device commercialization efforts through system planning, integration, and validation activities.
- Contribute to the development, review, and/or approval of SOPs and supporting work instructions.
- Deliver structured quality assurance activities and metrics to support efficient, cost-effective operations.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
