Quality Assurance Specialist
2 weeks ago
This is a hybrid position that combines hands-on software quality with broader quality system responsibilities. The ideal candidate has a strong quality mindset, thrives in highly regulated environments, and can work closely with cross-functional teams to drive process improvement.
About the Position- The role involves reviewing and approving technical documentation, maintaining risk assessments and traceability matrices for software compliance, and collaborating with software and systems engineers to ensure secure-by-design product development.
- You will also be responsible for supporting secure software development lifecycle and Cyber Security efforts, as well as general QA activities such as CAPA, change control, document review, and internal/external audits.
- 5+ years of experience in software quality engineering in similar highly regulated industries.
- Experience with relevant standards and frameworks like IEC 62304, ISO 14971, IEC 81001-5-1, FDA QSR, and ISO 13485.
- Some knowledge of cybersecurity risk frameworks is beneficial, such as NIST and ISO 27001.
This role offers opportunities for professional growth, collaboration with experienced professionals, and contribution to the success of our organization.
How You'll ContributeYou will play a critical role in ensuring the delivery of high-quality products and services that meet regulatory requirements and customer expectations.
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