What are the responsibilities and job description for the Quality Assurance Engineer position at Indotronix Avani Group?
Job Position: Quality Assurance Engineer
Duration: 12 months
Location: Irvine CA 92618
Job Description:
- Responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective. Generally matched to Quality Assurance in surveys.
- Preferred Bachelor’s degree in Engineering, Computer Science, or Health Science.
- Minimum 2 years of experience in the Medical Device, Life Sciences, or Healthcare industry.
- Expertise in extracting, filtering, validating, and downloading data from Power BI.
- Expertise in manipulating, and analyzing large datasets using advanced Excel functions and formulas (VLOOKUP, pivot tables, conditional formulas).
- Preferred experience with the ETQ Quality Management System.
- Experience in the post-market surveillance area (review of data and relationship to complaints).
- Understand the importance of quality compliance in the medical device industry, based on medical device industry data.
- Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards).
- Experience in Trackwise QMS is a plus.