Job Title : Software Quality Assurance (QA) Manager
Location : Santa Cruz
Job Summary : We are seeking an experienced Software Quality Assurance Manager to lead our QA team in ensuring the highest quality standards for software used in our medical devices.
The ideal candidate will have a strong background in software testing, quality management, and regulatory compliance, particularly within the medical device industry.
This role involves overseeing the development and implementation of test strategies, ensuring compliance with relevant standards, and driving continuous improvement in software quality processes.
Key Responsibilities :
- Lead the software QA team to develop, implement, and maintain test plans, test cases, and test scripts for software applications used in medical devices.
- Ensure software testing aligns with regulatory requirements, including ISO 13485, IEC 62304, and FDA standards.
- Collaborate with software developers, product managers, and other stakeholders to understand software requirements and specifications.
- Develop and enforce QA processes to ensure compliance, reliability, and safety of software products.
- Oversee the execution of manual and automated testing to identify software defects and track their resolution.
- Manage software validation activities, including risk assessments, traceability matrices, and documentation.
- Monitor and report on software quality metrics, providing insights for process improvement.
- Lead investigations into software issues, identifying root causes, and implementing corrective actions.
- Train and mentor the QA team on best practices, tools, and industry standards.
- Maintain up-to-date knowledge of software QA trends and emerging technologies in the medical device sector.
Qualifications :
- Bachelor’s degree in Computer Science, Software Engineering, or related field.
- Minimum of 5 years of experience in software quality assurance, with at least 2 years in a leadership role.
- Strong understanding of software development life cycle (SDLC) and software testing methodologies.
- Experience with regulatory requirements for medical device software (ISO 13485, IEC 62304, FDA).
- Proficient in using test management tools, bug tracking software, and automation frameworks.
- Excellent problem-solving, communication, and project management skills.
- Ability to work in a fast-paced environment and manage multiple projects simultaneously.
- Attention to detail and commitment to high-quality standards.
Preferred :
- Certification in Software Quality Assurance (e.g., CSQE, ISTQB).
- Experience in Agile / Scrum methodologies.
- Familiarity with risk management and cybersecurity standards for medical devices.
Why Join Us?
- Be a part of a dynamic team working on innovative medical devices that improve patient care.
- Opportunities for career growth and professional development.
- Competitive salary and benefits package.
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