Responsible for implementing and maintaining the effectiveness of the quality system. Perform routine testing (physical, chemical or functional) on product returned from the field due to a customer complaint, using a variety of lab equipment. Summarize and record all test data and maintain proper documentation of all lab work. Process customer returns in a timely manner in accordance with ISO and FDA QS Reg. Support company goal for timeliness of complaint investigations and closures. Knowledge of regulations and standards affecting IVD’s and Biologics. Must have good written and oral communications skills. Must possess good laboratory practices, including handling of chemicals and biohazardous material.
Entry Level Lab Technician in the Complaint Investigations Lab. The role would be responsible for: Investigating returned product in order to resolve customer complaints regarding their blood glucose meters, strips & sensors. Documenting the complaint investigations in the Complaint Handling System. The candidate will also use troubleshooting equipment like, multi-meters, oscilloscopes, test fixtures, microscopes, etc. to complete the investigation.
· Experience in Medical Device / Biotech Industry is preferred.
· Knowledge of Electronic Troubleshooting is preferred.
· Ability to work in a team setting is a plus.
· Fast learner and ability to follow written work instructions of SOP’s is preferred.
· Good documentation skills are a must.
· Good computer skills are essential for this job, since data entry of investigation results is a primary part of the job.
· Ability to focus while performing repetitive and routine investigations is a must.
· Great fit for workers with Manufacturing, Inspection, and Assembly experience.
· Minimum education required is H.S. Diploma or equivalent (such as GED).
· An Associates (Two year) degree in Electrical Engineering or other Science is a great fit for this job.
· Recent college graduates with a Bachelor’s degree in Engineering or other subject may be considered but candidates with a Bachelor’s degree are not an ideal fit for this entry level position.