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.