Senior QA Engineer supporting QA activities across web projects and WordPress websites in a hybrid setup. Involved in testing, documentation, and collaboration within Agile teams.
About the role
- Sr. Quality Engineer leading design control activities across Veracyte’s IVD product lifecycle. Ensuring compliance with regulatory requirements in a hybrid work environment across the United States.
Responsibilities
- Lead the design control activities across Veracyte’s IVD product lifecycle.
- Ensure compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other global regulatory requirements.
- Serve as the primary Quality partner to R&D and cross-functional teams.
- Drive robust design control execution, effective risk management, and sustained audit readiness.
- Participate in internal and external audits, serving as the SME for design control and risk management.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field.
- 7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry.
- In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and ISO 14971:2019 risk management.
- Hands-on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control.
- Strong problem-solving and organizational skills.
Benefits
- competitive compensation and benefits
- significant career opportunities
- employee engagement programs
- inclusive workforce environment
- flexible work arrangements
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
QA Engineer role ensuring product quality for Bamboo's fintech platform. Collaborating with teams and leading testing processes to enhance efficiency.
Software Quality Engineer focusing on Test Automation for product QA and Development teams. Involves scenario automation, team training, and agile participation based in Colombo, Sri Lanka.
Software Quality Engineer collaborating with teams to design performance test scenarios in Colombo. Involves training and updating product testing across agile sessions.
QA Tester ensuring product quality in a health tech scale - up. Collaborating with tech teams to improve testing processes and methodologies in an agile environment.
R&D Engineer focusing on test development for electronics at Hitachi Energy. Responsible for designing, implementing, and validating test solutions for advanced electronic products.
Supplier Quality Engineer ensuring quality of supplied components and products for Dentsply Sirona. Collaborating globally to optimize supplier relationships and processes while adhering to quality standards.
QA Technical Tester at Cigna Healthcare responsible for strategizing QA practices. Collaborating with teams to ensure quality delivery of products.
Lead Automation QA driving quality engineering strategy for Ventra's analytics platform built on Snowflake and Power BI. Collaborate with cross - functional teams to ensure data accuracy and reliability.
QA Engineer responsible for supporting testing activities of telephony software solutions at Saab, ensuring quality standards before deployment. Collaborating with development teams and influencing design decisions throughout product lifecycle.