Quality Assurance Engineer

Company: Impact Business Group Inc
Location: Solon
Posted on: April 2, 2025

Job Description:

Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Assurance Engineer for a 9 Month Contract opportunity. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Are you the right applicant for this opportunity Find out by reading through the role overview below.

This role will be responsible for supporting quality performance of the tube set production line. Additionally they will be responsible for troubleshooting issues related to manufacturing equipment including air compressors, ultrasonic welders, compressed air testers and measurement equipment.

MAJOR DUTIES/RESPONSIBILITIES:

Prepare and implement programs and processes to ensure compliance with the company's high quality standards.
Support validation, MSA remediation, PFMEA (Risk Management), PPAP, QMS integration: training, acceptance activities, part certification, NCs at suppliers and deep dive into P&PC.
Experience in medical device manufacturing and the FDA QSR are preferred.
WORKING CONDITIONSFast-paced office environment.
Medical Device, highly regulated environment.
Mission-oriented culture, energized by the knowledge that our products save lives every day, and our work here has a very material impact on the delivery of healthcare around the world.






Job Requirements


REQUIREMENTS

Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering
Minimum of 3-5 years in a quality role for a medical device company: this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.
Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable
Excellent verbal, written and interpersonal communication skills
Excellent problem solving and analytical skills
Excellent technical writing skills
High level of attention to detail and organization
Ability to multi-task and work independently
Ability to participate in cross-functional teams
Ability to read and interpret engineering drawings and other technical specifications preferred
Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)

Keywords: Impact Business Group Inc, Cleveland Heights , Quality Assurance Engineer, Engineering , Solon, Ohio