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Senior Software Quality Assurance Engineer
2 months ago
We are seeking an experienced Senior Software Quality Assurance Engineer to join our team at Vitalbio. As a key member of our QA team, you will play a crucial role in ensuring the quality and integrity of our software products.
Key Responsibilities- Quality Process Development: Collaborate with cross-functional teams to design, implement, and maintain software quality processes and procedures.
- Test Planning and Execution: Develop and execute comprehensive test plans, including validation plans, test protocols, and risk assessments, to ensure high-quality software releases.
- Documentation Management: Create and maintain accurate documentation, including software requirements documents (SRS/SDS), risk analysis documents, and test reports.
- Audit and Compliance: Participate in internal audits, manage audit responses, and ensure compliance with regulatory requirements, including FDA 21 CFR part 820, ISO 13485, and ISO 62304.
- Regulated Medical Device Experience: Proven experience in software quality assurance of regulated medical devices.
- Quality System Knowledge: Familiarity with quality system management principles, including design control, document control, change control, and risk management.
- Issue Tracking Tools: Experience using issue tracking tools, such as Jira.
- Communication Skills: Strong communication skills, with the ability to collaborate effectively with cross-functional teams.
- Software Development Lifecycle: Strong understanding of the software development lifecycle (SDLC), including both theoretical and practical aspects.
- ASQ CSQE Certification: Certified Software Quality Engineer (CSQE) certification from the American Society for Quality (ASQ).
- Auditing Experience: Prior experience conducting and supporting audits, internal and external.
- Software Development Experience: Familiarity with various software development approaches, from low-formality to full-formality.
- Programming Languages: Proficiency in programming languages such as Rust, Python, or Nix.
- FDA Regulations: Knowledgeable about FDA regulations and requirements associated with medical device cybersecurity concerns, quality processes, and deliverables.
$120,000 - $160,000 per year, depending on qualifications and experience.
