Quality Engineer - Barceloneta45

  • Contract

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

  • The main responsibilities of the line support quality engineer include, but are not limited to, the following: oversight of procedural readiness execution and remediation, measuring execution and effectiveness, track all quality improvement actions and projects in the area, monthly reporting on quality improvement activities, ownership of Quality Improvement projects (initiating Change Request / Change Order as necessary and overseeing the change was implemented and sustainable), and support to Investigations Engineers.
  • Will serve as primary QA personnel supporting the day to day manufacturing operations. 
  • Will have to create a strong teamwork with the line supervisor, investigations QE and ME service engineer to address all the opportunities found in the assigned manufacturing line. 
  • The incumbent will serve as the QA management representative in the manufacturing line, executing initiatives and working directly with the DL workforce.

Qualifications

  • Requires Bachelor degree, in Engineering. 
  • Minimum of 2 years of relevant experience in Quality and/or Compliance, preferably in medical device industry. 
  • Fully Bilingual (English/Spanish – both oral and written). 
  • Knowledge of applicable US non-US applicable regulations. 
  • Knowledge and proficiency in the application and principles of Quality Engineering. 
  • Ability to effectively communicate cross-functionally to assist with resolving Quality issues. 
  • Excellent written, verbal and interpersonal communication skills. Ability to evaluate complex processes. 
  • Ability to interact effectively with all levels of employees.
  • Should have experience in Process Engineer with CAPA.  
  • Will perform this job in a quality system environment and will complete duties or assume an investigator’s role.
  • The candidate must have availability to work at 2nd shift (from 1pm to 9pm or 2pm to 10pm)

Additional Information

  • Entry Level/Hourly position
  • Availability to work at 2nd shift (from 1pm to 9pm or 2pm to 10pm)
  • Send resume, preferable in Word format.