Jt321 - Quality Engineer II

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

The Contingent Engineer II will provide engineering support for validation, qualification, and process improvement activities within a regulated manufacturing environment. This role involves executing validation protocols, performing statistical analyses, preparing technical documentation, and collaborating with cross-functional teams to ensure compliance with applicable quality systems and regulatory requirements.

Essential Responsibilities: Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems. Develop, review, and execute validation protocols, including: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Process Characterization Studies Test Method Validation (TMV) Inspection Method Validation (IMV) Design of Experiments (DOE) Prepare, review, and maintain validation protocols, reports, and other technical documentation.

Utilize Minitab to perform statistical analyses, process capability studies, data trending, and DOE evaluations. Support investigations, nonconformance assessments, corrective and preventive actions (CAPAs), and process improvement initiatives. Analyze manufacturing and quality data to identify trends, assess process performance, and recommend improvements.

Collaborate with Engineering, Quality, Manufacturing, and Operations teams to support project execution and technical objectives. Ensure compliance with applicable quality system procedures, industry standards, and regulatory requirements.

Minimum Qualifications

Bachelor's Degree in Engineering Required. 2–3 years of relevant experience in engineering, validation, quality, manufacturing, or a related technical field.

Experience in a regulated manufacturing environment, such as Medical Device, Pharmaceutical, or Biotechnology. Working knowledge and experience with IQ/OQ/PQ protocol development and execution. Knowledge of process characterization and Design of Experiments (DOE) methodologies. Experience with Test Method Validation (TMV) and Inspection Method Validation (IMV).

Proficiency in Minitab for statistical analysis, data interpretation, and process evaluation. Strong technical writing and documentation skills. Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint. Strong verbal and written communication skills. Fully bilingual in English and Spanish (written and spoken).

Preferred Qualifications

Experience in medical device manufacturing. Knowledge of FDA regulations, Good Manufacturing Practices (GMP), and ISO 13485 standards. Familiarity with risk management tools, including Failure Mode and Effects Analysis (FMEA) and risk assessments. Experience with Microsoft Project. Previous experience supporting validation and process improvement projects in a regulated manufacturing environment.

First Shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.