Quality Engineer II

Weil Group, Inc; Ponce (PR); On-site; USD 55,000 - 83,000; Full time

Job summary

Weil Group, Inc. is seeking a Contingent Engineer II in a regulated manufacturing setting to support validation, qualification, and process improvements.

The role involves executing validation protocols, conducting statistical analysis with Minitab, and preparing technical documentation in collaboration with Engineering, Quality, and Manufacturing teams. Ideal candidates have 2–3 years in engineering/validation within regulated environments, strong writing and communication skills, and fluency

Qualifications

• Bachelor's degree in Engineering.
• 2–3 years of experience in engineering, validation, quality, manufacturing, or related field.
• Experience in a regulated environment (Medical Device, Pharmaceutical, Biotechnology) preferred.
• Fluent bilingual English/Spanish with strong written and verbal communication.

Responsibilities

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop and execute IQ, OQ, PQ, DOE, TMV, IMV, and Process Characterization studies.
• Generate and review validation protocols, reports, and technical documentation.
• Utilize Minitab for statistical analysis, data trending, and DOE analysis.
• Support investigations, nonconformances, corrective actions, and process improvements.
• Collaborate with Engineering, Quality, Manufacturing, and Operations to meet project objectives.

Skills

Bilingual English/Spanish

Strong writing & communication

Able to work cross-functionally

Education

Bachelor's in Engineering

Tools

Excel

Word

PowerPoint

Microsoft Project

Minitab

Job description

Contingent Engineer II – Validation & Quality Support

Position Summary

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.

Essential 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.

Minimum Qualifications

Education

Bachelor's Degree in Engineering

Experience

• 2 to 3 years of experience in engineering, validation, quality, manufacturing, or a related technical field.
• Experience within a regulated environment (Medical Device, Pharmaceutical, Biotechnology, or similar) preferred.

Required 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.

Preferred Qualifications

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

Weil Group is proud to be an Equal Employment Opportunity Employer.