Quality Engineer II

Echo-Consulting-Group; Villalba (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

ECHO Consulting Group, a leader in CQV and regulatory compliance, is seeking a Contingent Engineer II to support validation and process improvement in a regulated manufacturing setting.

The role focuses on executing IQ/OQ/PQ, DOE, and TMV/IMV studies, generating technical documentation, and collaborating with cross-functional teams to ensure quality and regulatory alignment.

Qualifications

• Bachelor’s degree in Engineering.
• Experience in medical device manufacturing.
• Knowledge of FDA, GMP, and ISO 13485 requirements.
• Familiarity with risk management tools (FMEA, risk assessments).

Responsibilities

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Generate and review validation protocols, reports, and technical documentation.
• Utilize Minitab for statistical analysis, process capability studies, data trending, and DOE analysis.
• Support investigations, nonconformance evaluations, corrective actions, and process improvement initiatives.
• Collaborate with Engineering, Quality, Manufacturing and Operations personnel to support project objectives.

Skills

MS Office

Technical writing

Verbal communication

Bilingual English/Spanish

IQ/OQ/PQ knowledge

Process characterization

DOE methodology

TMV/IMV knowledge

Minitab

Education

Bachelor’s degree in Engineering

Tools

Minitab

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

The Contingent Engineer II will support validation, qualification, and process improvement activities within a regulated manufacturing environment. The individual will be responsible for executing validation protocols, assisting with statistical analysis, preparing technical documentation, and collaborating with cross-functional teams to ensure compliance with quality and regulatory requirements.

Responsibilities:

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.

• Development and execution of:

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Process Characterization Studies

  • Test Method Validation (TMV)

  • Inspection Method Validation (IMV)

  • Design of Experiments (DOE)

• Generate and review validation protocols, reports, and technical documentation.

• Utilize Minitab for statistical analysis, process capability studies, data trending, and DOE analysis.

• Support investigations, nonconformance evaluations, corrective actions, and process improvement initiatives.

• Analyze manufacturing and quality data to identify trends and opportunities for improvement.

• Collaborate with Engineering, Quality, Manufacturing and Operations personnel to support project objectives.

• Ensure all activities are completed in compliance with applicable quality system and regulatory requirements.

Shift: 1st Shift

Location: Ponce,PR

Education: Bachelor’s degree in Engineering.

Preferred Qualifications:

• Experience in medical device manufacturing.

• Knowledge of FDA, GMP, and ISO 13485 requirements.

• Familiarity with risk management tools (FMEA, risk assessments).

Target Experience Level: 2–3 years

Skills:

• Proficiency in Microsoft Office Suite:

  • Excel

  • Word

  • PowerPoint

  • Microsoft Project (preferred)

• Strong technical writing and documentation skills.

• Strong verbal communication skills.

• Fully bilingual (English and Spanish), written and spoken.

• Working knowledge of:

  • IQ/OQ/PQ Protocol Development and Execution

  • Process Characterization

  • DOE Methodology

  • Test Method Validation (TMV)

  • Inspection Method Validation (IMV)

• Proficiency in Minitab for statistical analysis and data interpretation.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.