Open Position: Quality Associate

Function:  Quality Engineering

Summary

The Quality Associate uses basic knowledge of quality tools and their uses to support both EdgeOne and Client quality improvement projects as well as product development projects.

Please send your resume and a cover letter to career@edgeonemedical.com and include Quality Associate in the Title.

Essential Duties and Responsibilities

    1. Analyzes and solves quality problems related to QMS procedures.
  •  Prepares inspection plans and instructions for raw materials, testing and manufacturing.
  •  Supports sampling plan determination and implementation
  •  Prepares QMS and laboratory procedures and executes change control.
  • Delivers training for QMS procedures and testing protocols.
  •  Supports internal QMS audits, audits/quality checks of laboratory and manufacturing documentation and supplier qualifications.
  •  Analyzes quality data to support ongoing quality system improvement.
  •  Oversees document control/document management.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

    1. Able to describe key events in the evolution of quality systems.
  •  Recognize how basic quality tools can be used to help improve processes.
  •  Define different quality concepts related to quality evolution, process management, and the basic quality tools.
  •  Understand the importance of the customer-supplier relationship and team roles and responsibilities.
  •  Very familiar with GDP requirements and CAPA process.
  •  Bachelor’s degree in Engineering, Life Science, or Equivalent
  •  2-4 years of experience in Quality Systems.
  •  Familiarity with 13485 and 21CFR820 required.
  •  Strong multi-tasking, time management, technical writing, and communication skills are required.
  •  Highly motivated self-starter who can work with minimal supervision or as part of team.
  •  Ability to problem solve and identify root causes as part of investigations.

Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.