Location: Caguas, PR
Shift: Adminitsrative (8:00 AM - 5:00 PM)

Responsibilities:

• Support day-to-day manufacturing operations in AVPR as primary QA personnel.
• Create strong teamwork with the line supervisor, investigations QE, and ME service engineer to address opportunities found in the assigned manufacturing line.
• Serve as QA management representative in the manufacturing line.
• Execute initiatives and work directly with the DL workforce.
• Oversight of procedural readiness execution and remediation.
• Measure execution and effectiveness.
• Track all quality improvement actions and projects in the area.
• Prepare monthly reporting on quality improvement activities.
• Own Quality Improvement projects, including initiating Change Request / Change Order as necessary and overseeing implementation sustainability.
• Support Investigations Engineers.
• Develop product quality plans, documents, and quality systems.
• Provide input to product specifications, quality specifications, quality plans, risk analyses, and FMEAs in conjunction with project team members.
• Implement changes through the change management system and provide quality engineering impact assessments.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• Work on:
  • Validations (IQ/OQ/PQ)
  • Product Transfers (preferred but not required)
  • Capital Proyects
  • Continuos Improvment
  • Cost Improvement Projects

Qualifications:

• Bachelor’s Degree in Engineering field.
• Minimum of 2 years of relevant experience in Quality and/or Compliance, preferably in medical device industry.
• Experience working with validations in Medical Devices or Pharma.
• Fully bilingual in English and Spanish (oral and written).
• Excellent written, verbal, and interpersonal communication skills in both English and Spanish.
• Ability to work with minimum guidance.
• Knowledge of applicable US and non-US regulations.
• Knowledge and proficiency in the application and principles of Quality Engineering.
• Understands product quality plans, documents, and quality systems.
• Ability to effectively communicate cross-functionally to assist with resolving Quality issues.
• 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.