JOB PURPOSE:

To ensure on-going product quality through implementation of quality system processes and procedures.

ESSENTIAL DUTIES:

• Ensures regulatory requirements are met


• Defines and implements quality system processes and procedures


• Understands all aspects of assigned production line(s) in order to help minimize scrap and complaints


• Implements corrective actions and uses CAPA system to consistently improve product quality


• Prepares written protocols and reports


• Performs a variety of complex tasks using experience and judgment


• May lead and direct the work of others in various projects and assignments


• Upholds Xeridiem vision and core values

• Performs other duties as required

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

Required:

• Applicable Bachelor’s degree and/or equivalent experience in a related field


• Has knowledge of commonly-used concepts, practices, and procedures within field, including regulatory affairs


• Ability to problem solve, identify errors and deficiencies and perform research independently


• Ability to apply knowledge to their job function using pre-established guidelines and instructions


• Accuracy, attention to detail, and thoroughness


• Proficient computer skills


• Proficient communications skills


• A wide degree of creativity and latitude


• Ability to comprehend and comply with company safety and quality standards


• Ability to follow oral and written instructions

Preferred:

• Previous experience in Quality Assurance


• Rudimentary knowledge of statistics


• Medical device experience


• 10 years directly related experience

WORKING CONDITIONS:

This position requires about 50% of time spent sitting and working on computer.  The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.