remote
Senior Quality Assurance Engineer - Coltene SciCan
QA Engineer
Senior Quality Assurance Engineer driving compliance, audit management, and continuous improvement in medical device manufacturing using ISO 13485, FDA 21 CFR Part 820, and automated testing with Selenium and TestNG.
About the role
Key Responsibilities
- Lead end‑to‑end QA activities for sterilization and disinfection equipment, ensuring adherence to ISO 13485 and FDA 21 CFR Part 820.
- Design, develop, and maintain automated test suites using Selenium and TestNG to validate product functionality and regulatory requirements.
- Coordinate internal and external audits, prepare audit documentation, and implement corrective actions to sustain compliance.
- Collaborate with cross‑functional teams (Engineering, Regulatory, Production) to define test plans, risk assessments, and quality metrics.
- Drive continuous improvement initiatives, analyze defect trends, and recommend process enhancements to reduce cycle time and improve product quality.
Requirements
- 5+ years of QA experience in medical device or sterilization equipment manufacturing.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GxP regulations.
- Proficiency in Selenium, TestNG, and test management tools such as JIRA.
- Excellent analytical, communication, and problem‑solving skills.
- Experience with risk management and CAPA processes is a plus.
Skills
test automationseleniumtestngjira