Quality Engineer 65
- Caguas, Caguas, Puerto Rico
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
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- Will serve as primary QA personnel supporting the day to day manufacturing operations
- 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
- Serve as the QA management representative in the manufacturing line, executing initiatives and working directly with the DL workforce.
- 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
- 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, and to interact effectively with all levels of employees
- Send resume, preferable in Word format.
QRC Group, LLC is an Equal Employment Opportunity Employer, and provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.