Quality Engineer

Function:
Regulatory Affairs/Quality Assurance (RA/QE)

Summary

Edge One Medical is an ISO 13485 certified Contract Development Organization specializing in the development and testing of medical devices and device combination products. Edge One is seeking an individual who is detail oriented and organized, proficient with prioritization of multiple tasks, and has a desire to learn to join our growing Quality team as a Quality Engineer.

This role is on-site in Wheeling, IL, and we are currently considering local candidates only. Relocation assistance is not available for this role.

In this role you will be responsible for leading Quality Engineering activities for laboratory projects to confirm that the activities and resulting documentation are compliant with quality system requirements, and current good documentation/laboratory practices (cGDP/cGLP). The projects include, but are not limited to:

• Equipment qualification, calibration, and maintenance
• Test method development and validation
• Test fixture qualification
• Testing protocols and reports

You will also support Quality Engineering activities for design control / development projects under the direction of the project Quality or R&D lead. Activities include, but are not limited to, the support of:

• Development of requirements including defining user/product requirements with translation into design inputs
• Risk management activities including creation of hazard analysis and failure analysis
• Translation of design input requirements into a verification and validation testing plan with consideration of test flow to maximize efficiency and minimize total sample size.

Essential Duties and Responsibilities

• Reviews and signs off on quality records and related documentation for compliance with operating procedures, protocols, reports, work instructions, laboratory notebooks, raw data, etc.
• Provides guidance on quality engineering related topics for laboratory projects.
• Supports Quality Engineering and R&D to complete testing development activities.
• Identifies and resolves minor compliance concerns, communicates major concerns to Quality management for resolution.

To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Demonstrated ability through education or previous employment:

• Degree in Biomedical Engineer or Mechanical Engineering
• 3+ years experience with laboratory testing and test method validation, protocol and report authoring/approval for medical device testing.
• Detail oriented and ability to focus on tasks.
• Good communication skills and well-organized

Edge One Medical is an equal opportunities employer. 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.