Quality Release Technician I

Job description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

This position is responsible for conducting documentation review, inspection of materials or product and release activities in a routine basis as part of the manufacturing processes. They may also provide assistance to engineers in providing quality technical support within new product development, manufacturing, or system/services support.

MAIN RESPONSIBILITIES

· 
Perform raw material, in process and final product inspections against specification and procedural requirements, including documentation review of the device history record as applicable.

· 
Audit production operations as applicable, including documenting inspection.

· 
Document and assist in the resolution of nonconformances as required.

· 
Perform process control and monitoring of critical-to-quality parameters and specifications.

· 
Collect data, summarize, analyze, perform basic statistical analysis, and document test results.

· 
Assist in the documentation of nonconformances as appropriate and assist in the resolution of nonconformances.

· 
Maintain control plans for products and processes.

· 
Assist and maintain area release goals are within the expected levels to avoid line down or back-order events.

· 
Support operations team on documentation error resolution.

· 
Performs other duties as assigned.

QUALIFICATIONS

· 
9th grade degree required.

· 
1 year prior medical device experience.

· 
Basic use of MS Office software.

· 
Knowledge on good documentation practices.

· 
Basic English level.

· 
Available to work 100% on site.

· 
Shift B (Monday to Friday 3:30 pm to 10:00 pm and Saturday 8:00 a m to 3:30 pm).

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The base pay for this position is
N/A/hour

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

SH Structural Heart

        

LOCATION:

Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Crcww1Dy (Costa Rica)

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Work in a clean room environment