Principal Quality Engineer

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:  Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.  Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.  Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.  May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Qualifications: Bachelor Degree in Engineering  Seven (7) years of previous experience Manufacturing in regulated industry – preferably Medical Device (cGMP, GDP, line clearance, device history records (DHRs) Thrives in predictable day to day hands on work content using hand tools, computer systems interfaces, and moving material up to 50 lbs. Enjoys working in a fast-paced 'can-do' environment executing consistently to work instructions. Knowledge in CSV full cycle Knowledge in Process Validation Full Cycle, FAT, SAT, IQ, TMV, CSV, PCR, OQ and PQ Knowledge in GAMP principles, basic software change knowledge, Validation Statistics Knowledge. 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. Powered by JazzHR