Quality Engineer

JOB PURPOSE:

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

ESSENTIAL DUTIES:

• Ensures regulatory requirements are met
• Understands all aspects of assigned production line(s) in order to help minimize scrap and complaints
• Implements improvements using the CAPA system
• Prepares written protocols and reports
• Responsible for managing and scheduling the routine sterilization validations.
• Writing, reviewing, approving sterilization technical protocols and report
• Assists with maintaining established departmental policies and procedures, objectives, and quality improvement, safety, and environmental standards.
• Performs a variety of tasks using experience and judgment
• 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, and a minimum of 5 years directly related experience
• 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 with limited guidance
• Ability to apply knowledge to their job function using pre-established guidelines and instructions
• Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)
• Accuracy, attention to detail, and thoroughness
• Proficient computer skills
• Proficient communications skills
• A certain 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

WORKING CONDITIONS:

Works under general supervision. Primary job functions do not typically require exercising independent judgment. 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.