Quality Engineer, Dorado

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved . Purpose Statement 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, Characterization, OQ/ PQ); process performance qualification activities and develop Master validation plans for new processes or products. Responsible for reviewing process validation protocols and reports. Support other functional areas during the validation activities. Collaborate with the Process Development team to efficiently qualify new processes; assist on 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 the test methods developed. Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary rootcauses and implementing corrective and preventative actions. May be responsible for querying&bounding data to support implementation of complex&documenting release criteria. May be responsible for creating risk analyses and FMEAs. Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation to reduce/eliminate the cause of defects. Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development. Assists in creation of Quality Tools&Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools&materials. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned. Minimum Qualifications Bachelor’s Degree in Engineering (Mechanical, Chemical, Industrial, Electrical, or related field). Experience in pharmaceutical, biotechnology, or medical device industries (preferred). Strong knowledge of validation processes (IQ/OQ/PQ), cGMP, and regulated environments. Experience with root cause analysis, CAPA, risk management, and statistical analysis tools. Familiarity with quality systems, audits, and compliance standards. Excellent problem-solving, analytical, and organizational skills. Strong communication skills and ability to work cross-functionally. Bilingual (English/Spanish) preferred.Proficiency in MS Office tools. 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.