Quality Engineer

: The line support quality engineer will serve as primary QA personnel supporting the day to day manufacturing operations. The individual performing this role 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 workforce.

:

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.

:

The person selected will be working within the Quality organization implementing Data Integrity initiatives, including but not limited to: assessments, validation protocols/reports, equipment qualifications, establishing software connectivity to manufacturing equipment, document change management, developing training content, exception investigations and problem:solving, among others.
Requirements

:

Bachelor degree, in Chemical, Industrial or Mechanical 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.