Biomedical Quality Technician
4 weeks ago
A Biomedical Quality Technician position in Irvine, CA is available courtesy of Akkodis.
- Type: Contract
- Duration: 3 months; possible extension
- Location: Irvine, CA
- Range: $27.11
Biomedical Quality Technician
RESPONSIBILITIES:
- Responsible for inspection and testing of assigned medical device components in accordance to QSR, company policy and approved procedures.
- Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and policies, procedures and guidelines, this position:
- Responsible for communicating business related issues or opportunities to next management level.
- Performs other duties assigned as needed.
- Performs dimensional and visual inspection of assigned products per approved procedures / inspection plans.
- Documents all inspection / test results and any non-conformances found during inspection, testing or evaluations according to the written procedure.
- Performs disposition of material.
- Maintain knowledge of all procedures, change to specifications and new regulations related to areas of responsibilities.
- Review supplier inspection / test results; provide feedback to engineers and suppliers.
- Support associates on defect awareness, inspection methods and specifications requirements.
- Perform device History Records (DHR) / batch records review for product release.
- Support in training of new QA Technician for proper use of inspection methods and procedures.
REQUIREMENTS:
- Minimum of 1 years of related work experience in Biomedical, Pharmaceutical or similar environment.
- 1 or more years of experience reviewing Batch Records or DHR' (or similar documents) a must.
- Verbal and written communication skills.
- Experience with ERP systems (Oracle preferred).
- Proficiency in Salesforce a plust.
- PC Literacy and use of Microsoft office.
- Be able to read and interpret engineering drawings a plus.
- Knowledge of ANSI-Z-1.4 and 1.9 lot sampling a plus.
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