Quality Engineer

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.

Position Summary:

The Quality Engineer develops and reviews documentation and procedures and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.

Key Responsibilities:

Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master Validation Plans for new processes or products.

Review process validation protocols and reports; support other functional areas during validation activities.

Collaborate with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans and other development procedures.

Design and develop in-process and receiving quality systems for new processes and components.

Define gages, tools, and equipment for developed test methods.

Identify and control manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in root cause analysis and implementing corrective and preventive actions.

Develop product quality plans, specifications, and risk analyses (including FMEAs) in conjunction with product development teams.

Develop process monitoring systems by identifying critical process steps and applying methods to reduce variation and defects.

Lead process improvement efforts by capturing quality metrics and performing analysis to enhance product design and development.

Assist in creating quality tools and training materials to improve effectiveness.

Evaluate adequacy and compliance of systems, operations, and practices against regulations and company documentation; may serve as auditor for development and manufacturing areas. Qualifications:

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field).

2–4 years of experience in an engineering role within a regulated industry (pharmaceutical, biotech, or medical device preferred).

Excellent communication (Spanish/English) and teamwork abilities. This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.