Quality Engineer – Manufacturing QA (Medical Devices & Pharma)

FITS LLC; Caguas (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a QA/Quality Assurance professional with a Bachelor’s in Engineering and at least two years of experience in quality or compliance within medical device or pharmaceutical industries. The role focuses on supporting day-to-day manufacturing QA activities and enforcing procedural readiness.

You will collaborate with line supervisors, quality engineers, and manufacturing engineers; manage change requests; track improvements; and report monthly on quality

Qualifications

• Bachelor’s degree in engineering with 2+ years QA/compliance in medical device or pharmaceutical industries.
• Bilingual in Spanish and English.

Responsibilities

• Serve as the primary QA support for day-to-day manufacturing operations.
• Collaborate with Line Supervisors, Investigation Quality Engineers, and Manufacturing Engineers to address manufacturing line opportunities.
• Serve as the QA Management Representative on the manufacturing line and work directly with the production workforce.
• Oversee procedural readiness, execution, remediation, and effectiveness.
• Track and report Quality Improvement actions and projects.
• Provide monthly reporting on quality improvement activities.
• Lead Quality Improvement Projects, including initiating Change Requests / Change Orders as necessary.
• Ensure implemented changes are effective and sustainable.
• Provide support to Investigation Engineers as needed.

Skills

Bilingual (Spanish and English)

Quality & Compliance experience

QA in Manufacturing

Communication skills

Education

Bachelor’s Degree in Engineering

Job description

FITS LLC in Puerto Rico is seeking a QA/Quality Assurance professional with a Bachelor’s in Engineering and at least two years of experience in quality or compliance within medical device or pharmaceutical industries. The role focuses on supporting day-to-day manufacturing QA activities and enforcing procedural readiness.

You will collaborate with line supervisors, quality engineers, and manufacturing engineers; manage change requests; track improvements; and report monthly on quality