Quality Engineer

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

For quality services in the engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Engineering field and minimum of two (2) years of experience Quality and/or Compliance in the Medical Device or Pharmaceutical industry regulated industries.
• Bilingual (Spanishand English).
• Excellent communication skills
• Shift: Administrative& according to business needs.
• Experience in:
  • Capital Projects
  • Cost Improvement Projects
  • IQ/OQ/PQ validations or Product Transfers is preferred but not required.
  • Quality Systems, Risk Assessments, and FMEAs.
  • Change Management and impact assessments.
  • Qualification and validation protocols/reports.
  • Monitoring project progress and deliverables.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

Key Responsibilities include, but are not limited to, the following:

• Serve as the primary Quality Assurance (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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?