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Quality Assurance Specialist
hace 2 meses
Quality Engineer
We are seeking a highly skilled Quality Engineer to join our team at Tacna/ Outset. As a Quality Engineer, you will be responsible for ensuring the quality of our products and processes.
Key Responsibilities:- Review systems and processes to identify areas for improvement and develop strategies for continued improvement through data analysis.
- Support or execute change orders for process improvements and determine when process stability and capability studies should be performed on existing processes.
- Analyze and perform failure analysis (investigations) to non-conforming products.
- Lead in the implementation of assurances, process controls, nonconformances, and CAPA.
- Support process validations for manufacturing processes (IQ, OQ, or PQ).
- Develop and prepare monthly quality trend analysis and reports.
- Bachelor's degree in engineering or technical field or equivalent experience.
- Minimum of 5 years of quality experience in a medical device or other regulated industry.
- Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO.
- Ability to read and understand technical data (drawings, GD&T, etc).
- Lead Auditor certification a plus.
- Competent using Microsoft Office suites.
- Experience with statistical analysis software a plus.
- Experience with environmental and microbiological testing, such as non-viable and viable particles counting.
- Cleanroom environment sustaining.
- Sterilization concepts and product release.
- Contractor management, such as external laboratories and sterilization sites.
English: 90%
Work Schedule:Full-time
Salary:$2, $3,000.00 per day
Questions:- What is your level of English?
- Do you have a valid Visa?
- How many years of experience do you have in the medical industry?
