Job Description

The following is not intended to represent an all-inclusive list of job responsibilities, but to outline the ESSENTIAL FUNCTIONS of the position.

The Quality Assurance Inspector (QAI) is responsible for quality assurance and quality control activities through all the applicable processes. Perform dimensional and visual test of processes and product in order to ensure fulfillment of customer’s specifications.

Function:

Perform periodical process audits Ensure process parameters are operating in a defined range accordingly with the documented procedures Ensure appropriate identification of product status Ensure GMP for quality records Monitor and analyze test’s outputs trend charts Ensure the integrity of data Perform periodical inspection of incoming material, WIP, processes, and finish good Collaborate in root cause analysis efforts Participate in continuous improvement activities Participate on any other assigned activities

Supervisory Responsibilities:

N/A

Physical Requirements:

• Sedentary Work:  Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc.  Generally involves sitting most of the time.
• Must be able to review printed material.
• Must be able to communicate with others telephonically. 
• Ability to operate in a fast paced environment, sometimes requiring extended work hours.

Required Skills:

SPC Inspection routines. ISO 13485 basic Problem Solving Microsoft

• Spanish

Required Education and Training:

Mid school, high school preferred, plus 1 to 3 of experience in similar roll,

• SPC basic

• Considerable knowledge of quality systems for medical devices

• Proficient in MS Office Suite (including Word, Excel and Power Point),

Pay rate will not be below any applicable local minimum wage rates.