Quality Engineer

FITS LLC; Añasco, Northern (PR, KY); Hybrid; USD 90,000 - 140,000; Full time

Job summary

FITS LLC in the United States is seeking a Quality Engineer to develop, implement, and maintain quality systems in line with FDA, QSR, ISO, and regulatory guidelines. You will lead quality activities for manufacturing processes, validate systems, and support audits.

The role requires a Bachelor’s degree in Engineering and at least five years of relevant experience, with proficiency in Spanish and English. You will collaborate with cross-functional teams to ensure product quality and regulatory

Qualifications

• Bachelor's degree in engineering and 5+ years in pharma/medical devices quality.
• Bilingual in Spanish and English.
• Experience with FDA, QSR, ISO, and validation activities.

Responsibilities

• Develop, implement, and maintain quality systems per FDA, QSR, and ISO.
• Lead quality engineering for manufacturing processes and validations.
• Prepare and review validation protocols and change controls.
• Support qualification activities for facility additions including HVAC systems, water filtration systems, cleanroom environments, and related utilities.
• Analyze quality and process performance data using statistical tools to identify trends and continuous improvement initiatives.
• Participate in internal and external audits, supporting audit preparation, execution, responses, and follow-up activities.
• Lead problem-solving efforts utilizing Root Cause Analysis, CAPA methodologies, and quality improvement tools.
• Collaborate with cross-functional teams to ensure product and process quality throughout the product lifecycle.

Skills

Quality engineering

Bilingual Spanish/English

Statistical analysis

Lean Manufacturing

Six Sigma

Root Cause Analysis

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering

Tools

Validation Protocols

Validation Plans

SOPs

Change Controls

Investigations

Gage R&R

Minitab

SPC

DOE

Process Validation

HVAC Systems Qualification

Job description

For Quality Engineering servicesin the Manufacturing and Quality Systems area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Engineering and at least five (5) years of experienceto Quality activitieswithin the Pharmaceutical or Medical Devices industry.
• Bilingual (Spanishand English)
• Shift: Administrative& according to business needs
• Experience in Medical Devices, Lyophilization, Biomaterials, cGMP, Cleaning Methods, and Validation activities is preferred.
• Experience in:
  • ISO Cleanrooms, Quality System Regulation (QSR), ISO standards, Design Controls, and Process Validation.
  • Qualification of facility systems including HVAC and water filtration systems.
  • Statistical analysis and quality tools such as SPC, DOE, Process Capability, Gage R&R, and Minitab.
  • Lean Manufacturing, Six Sigma methodologies, Risk Management, and RootCause Analysis.
  • Technical documentation development including Validation Protocols, Validation Plans, Investigations, SOPs, Change Controls, and Technical Reports.

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 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 take on this new challenge?

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• Develop, implement, and maintain quality systems in accordance with FDA, QSR, ISO, and applicable regulatory requirements.
• Lead and support quality engineering activities related to manufacturing processes, facility qualifications, and process validations.
• Prepare, execute, and review validation protocols, validation plans, change controls, technical reports, investigations, and standard operating procedures.
• Support qualification activities for facility additions including HVAC systems, water filtration systems, cleanroom environments, and related utilities.
• Analyze quality and process performance data using statistical tools to identify trends, opportunities, and continuous improvement initiatives.
• Participate in internal and external audits, supporting audit preparation, execution, responses, and follow-up activities.
• Lead problem-solving efforts utilizing Root Cause Analysis, CAPA methodologies, and quality improvement tools.
• Collaborate with cross-functional teams to ensure product and process quality throughout the product lifecycle.
• Support risk management activities, reliability assessments, and quality planning initiatives.
• Drive Lean and Six Sigma initiatives to improve operational efficiency, compliance, and overall product quality.

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?