Job Details
Description
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
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.
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