Summary

• Performs quality document review activities in accordance with established procedures.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Reviews, files, and maintains Quality Documentation.
• Responsible for production inventory management
• Assist with the creation and edits of Quality Procedures and SOPs
• Responsible for manufacturing floor audits
• Assist with Contract Review Files
• Assist in ECO and Non-conformance processes
• Assist with internal/external audits and preparation
• Assist with updating and reviewing electronic QMS trackers
• Responsible for assuring that assigned activities are performed in accordance with Memphis Quality Management System.

Competencies To perform the job successfully, an individual should demonstrate the following competencies:

• Use of Technology - Demonstrates required skills.
• Personal Effectiveness/Credibility.
• Thoroughness.
• Communication Proficiency.
• Flexibility.

Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• High School Diploma or GED required
• Familiar with FDA Quality System Regulations and ISO 13485 Standard.

Language Skills

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees of organization.

Mathematical Skills

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Reasoning Ability

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills

• Knowledge of Microsoft Office applications (Word, Excel, Outlook)

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Additional Notes

ARCH Global Holdings is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Holdings employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.