Quality Engineer

Ultimate Solutions Corp; Puerto Rico; Presencial; COP 238.768.000 - 312.236.000; Jornada completa

Descripción de la vacante

A leading compliance and technology solutions provider is seeking a Quality Engineer in Puerto Rico, Meta, Colombia. This role involves supporting quality and compliance activities within a regulated Medical Device environment. Responsibilities include equipment validations, test method validations, documentation review, and support for quality investigations. Candidates should have a Bachelor’s degree in Engineering or Sciences, 3-5 years of experience in a regulated industry, and be bilingual in English and Spanish. Competitive salary and opportunities for growth are offered.

Formación

• 3–5 years of relevant experience in a regulated industry.
• Solid knowledge of statistics and problem-solving methodologies.
• Ability to work effectively in a team-based environment.

Responsabilidades

• Execute equipment validations in a Medical Device environment.
• Perform and support test method validations.
• Support and lead quality investigations and documentation.
• Review and approve controlled documents as per procedures.
• Design and implement system or process improvements.
• Develop and maintain Sampling Plans based on risk.
• Support Change Control activities including cross-functional coordination.
• Create and maintain pFMEA documentation.
• Ensure compliance with GMP, ISO, and regulatory requirements.

Conocimientos

Experience in Medical Device or Pharmaceutical industry

Knowledge of GMP and ISO standards

Proficiency with MS Office applications

Knowledge of statistics and Lean tools

Team collaboration skills

Strong organizational skills

Effective communication skills

Bilingual in English and Spanish

Educación

Bachelor’s degree in Engineering or Sciences

Herramientas

MS Office Suite

MS Project Management tools

Descripción del empleo

About Ultimate Solutions Corp.

Ultimate Solutions Corp. is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Sciences industry. With over 20 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to successfully support clients worldwide.

Position Summary

The Quality Engineer will support quality and compliance activities within a regulated Medical Device environment. This role is responsible for equipment (testing) validations, test method validations, documentation review and approval, and support of quality investigations and CAPAs. The candidate will apply Quality Engineering principles and Six Sigma / Lean tools to drive continuous improvement and implement system or process modifications.

Responsibilities

• Execute equipment (testing) validations in a Medical Device environment, including protocol development, execution, and final reports.

• Perform and support test method validations to ensure compliance with intended use and regulatory requirements.

• Support and/or lead quality investigations, including deviations, nonconformances, root cause analysis, and documentation.

• Support the development, execution, and effectiveness verification of CAPAs.

• Review, revise, and approve controlled documents (SOPs, protocols, reports, forms) in accordance with document control procedures.

• Apply Quality Engineering principles and Six Sigma / Lean tools to design, evaluate, and implement system or process improvements.

• Develop, implement, and maintain Sampling Plans based on risk and statistical rationale.

• Support and execute Change Control activities, including impact assessments and cross-functional coordination.

• Create, review, and maintain pFMEA documentation to identify, assess, and mitigate process risks.

• Ensure compliance with GMP, ISO, and applicable regulatory requirements.

Education

• Bachelor’s degree in Engineering or Sciences.

• 3–5 years of relevant experience in a regulated industry.

Requirements / Skills

• Required experience in the Medical Device or Pharmaceutical industry.

• Strong knowledge and practical experience with GMP and ISO standards.

• Strong computer skills, including proficiency with MS Office applications (Word, Excel, Outlook) and MS Project Management tools.

• Solid knowledge of statistics, problem-solving methodologies, and Lean tools.

• Ability to work effectively in a team-based environment.

• Demonstrated ability to be a team player, self-starter, persistent, tactful, and persuasive.

• Strong organizational skills, attention to detail, analytical thinking, and accuracy.

• Effective verbal and written communication skills, including technical writing and presentations.

• Ability to work with minimal or no supervision.

• Fully bilingual in English and Spanish.

Ultimate Solutions Corp. is an Equal Opportunity Employer.