Location: Caguas, PR

Purpose:
The line support quality engineer will serve as primary QA personnel supporting the day to day manufacturing operations in AVPR. 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 DL workforce.

Responsibilities:

• Understands product quality plans, documents, and quality systems.
• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other project team members.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• 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.

Requirements:

• 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. 

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 25.63/hr.