JT563 - SR QUALITY ENGINEER

QUALITY CONSULTING GROUP, a leader inthe 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:

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
• 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
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
• 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
• Equipment & Process Validation
• Quality Systems & Change Control
• Regulatory Compliance & Manufacturing Change Management

Qualifications:

• 4+ years of experience in related area
• Expertise in developing, reviewing, approving and executing validation strategies and deliverables associated with equipment qualification (IQ/CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments.
• Strong knowledge of Quality Management Systems (QMS), including change control, risk management, nonconformance investigations, and assessment of quality impact resulting from equipment, facility, and process changes.
• Experience evaluating regulatory impact associated with facility modifications, equipment relocations, and process changes, ensuring compliance with FDA, ISO 13485, and applicable global regulatory requirements.
• Strong expertise in equipment and process validation (IQ/OQ/PQ), including requalification for new, modified, or relocated equipment
• Experience supporting equipment purchases, relocations, and decommissioning with full quality and compliance oversight
• Experience ensuring audit-ready documentation and compliance with internal and regulatory requirements