Quality Assurance Engineer
Shoolin Inc
Job Description
This position is open exclusively to people who are eligible to work in USA Overview We are seeking a Quality Assurance Engineer to support quality systems and ensure compliance in regulated environments. The role focuses on maintaining product quality, supporting audits, and driving continuous improvement initiatives. Required Experience 2-4 years of experience in Quality Assurance within Pharma / Medical Device / Life Sciences industry Strong knowledge of GMP and FDA regulations (21 CFR Part 11 / 21 CFR Part 820) Experience with deviation, CAPA, and change control processes Hands-on experience with quality documentation and audits Knowledge of ISO 13485 and/or ISO 9001 standards Key Responsibilities Ensure compliance with GMP, FDA, and quality standards Manage and review deviations, CAPA, and change control records Support internal and external audits and regulatory inspections Review and approve quality documentation including SOPs and reports Conduct root cause analysis and implement corrective/preventive actions #J-18808-Ljbffr