JT563 - SR QUALITY ENGINEER

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group is seeking a talented professional to join our team in Puerto Rico & USA. The role focuses on developing, validating and maintaining quality standards for manufacturing processes and materials.

You will collaborate across engineering, manufacturing and quality to ensure robust QA systems and regulatory compliance. Responsibilities include designing inspection mechanisms, implementing testing protocols, and ensuring audit-ready documentation in GMP-regulated environments.

Qualifications

• 4+ years of experience in quality or validation roles.
• Expertise in developing, reviewing, approving and executing validation strategies and deliverables (IQ/CSV/OQ/PQ).
• Strong knowledge of QMS, change control and risk management.
• Experience with FDA, ISO 13485 and global regulatory requirements.

Responsibilities

• Develop and maintain quality standards and protocols for materials processing to finished products.
• Collaborate with engineering and manufacturing to ensure quality controls are in place.
• Design and implement inspection and testing strategies; perform statistical analysis on products and processes.
• Ensure documentation and records are audit-ready and compliant with requirements.
• Support equipment validation and change control activities, including IQ/OQ/PQ and requalification.

Skills

Validation strategies

Quality systems

Regulatory compliance

GMP environments

Equipment qualification

Documentation quality

Job description

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