Quality Assurance Lab Technician 1
||Wednesday, December 12, 2018
Decontaminate and evaluate returned Customer Complain Products by performing visual, functional, electrical, mechanical, and chemical testing, when appropriate. Provide evaluation results/reports for complaint files per procedural requirements.
Duties & Responsibilities:
- Decontaminate returned customer complaint product per established procedures. Coordinate off-site decontamination with approved vendor when decontamination cannot occur on-site.
- Using various lab test equipment perform product evaluations and testing according to procedures, protocols, established methods, and standards, in support of customer complaint investigations. Document the evaluations per established procedures.
- Manage in-process workload ensuring FIFO and Adverse Event Reportability are priority.
- Work with suppliers and OEM to coordinate the return of complaint product for evaluation by the vendor.
- Assure test equipment is properly calibrated or has had the appropriate preventative maintenance for customer complaint testing.
- Provides management with a weekly update on the status of in-process activities in the lab.
Work and Education Experience:
- 0-3 years working in a lab environment, preferably a medical device manufacturer test lab. Familiarity with using Word, Excel and Minitab.
- AAS in a science/technical discipline, or equivalent.
- Basic knowledge of GMP/QSR regulations and knowledge of MDR reporting requirement desirable.
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