Regulatory Technicain II - Temp.

Job Summary ?

 

Under minimal supervision, perform technical failure analysis of product related complaints. Performs customer complaint investigations. 

 

General Functions ?

Perform technical failure analysis and investigation of product complaints and failures. Failure analysis can include, but is not limited to, inspection using blueprints, diagrams, specifications, micrometer, thread gauge, caliper, optical comparator, concentricity gauge and height and depth gages. Investigation may include, not is not limited to, contacting customers to obtain additional information, identifying and recording problems with product quality and replying to customers on complaint findings. 

 

Prepare, process and complete complaint investigations, reports and records in accordance with established procedures.

 

Determine and document within complaint record whether investigation is necessary. 

 

Review complaint investigations, reports and records for completeness before closure of complaint file according to established procedures.

 

Prepare and send complaint acknowledgement to customers according to established procedures.

 

Monitor and report status of complaint investigations on a weekly basis. 

 

Hazards:  Potential exposure to blood borne pathogens

 

All employees are expected to perform their duties within their ability as required by the job or as directed by management.

 

 

 

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA

 

Regulatory Affairs Technician I

 

 

Expected Areas of Competence (i.e. KSAs) ?

? Considerable care and attention is required. Perform skilled inspection, and investigation work involving close tolerances and a great variety of details and dimensions.

? Considerable degree of precision and accuracy required. Requires concentration to study drawings having involved details and views; close degree of visual attention required to take precise instrument reading and to follow precise analytical procedures; check and compare product under investigation to specified Quality Assurance standards; and adhere to close tolerance.

? Highly motivated, self starter willing to meet strict deadlines and time constraints.

? Considerable care and attention required to prevent damage to hand-held measuring devises, and optical comparator.

? Work is performed in an office environment.  Some investigation tasks may be performed in a laboratory environment, with exposure to disagreeable elements.

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Education Requirements ? High school education or equivalent

 

Job Training and Experience: Two- four years of previous inspection experience and/ or investigation experience. Must achieve minimum competency in 4-8 weeks of on-the-job training.

 

Skill Requirements ?

?  Ability to use hand-held measuring devices, and optical comparator. 

?  Ability to read blueprints and interpret ANSI Y14.5

?  Competent in MS Office Applications

?  Extraordinary organization skills.

?  Detail-oriented