JT563 - SR QUALITY ENGINEER
About The Position
QUALITY CONSULTING GROUP is seeking a Senior Quality Engineer to contribute to pharmaceutical, biotech, medical device, and manufacturing work in Puerto Rico and the USA. The role focuses on establishing and maintaining quality standards, equipment and process validation, quality systems, change control, and regulatory compliance in GMP-regulated environments. The engineer develops and maintains standards and protocols for processing materials into partially finished or finished products; works with engineering and manufacturing to ensure quality standards are in place; and establishes methods for inspecting, testing, and evaluating products and production equipment. The role also includes specifying inspection and testing mechanisms, conducting quality assurance tests and statistical analyses, ensuring corrective measures meet reliability standards, and maintaining compliant documentation. Quality specialties may include design, incoming materials, production control, product evaluation and reliability, inventory control, and research and development as they relate to product or process quality.
Requirements
- Bachelor's degree in engineering.
- At least 4 years of experience in a related area.
- Expertise developing, reviewing, approving, and executing validation strategies and deliverables for equipment qualification (IQ/CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification 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.
- Availability for first shift.
Responsibilities
- Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests and statistical analyses to assess costs and determine responsibility for products or materials that do not meet standards and specifications.
- Ensure corrective measures meet acceptable reliability standards and documentation complies with requirements.
- Support equipment and process validation, quality systems and change control, and regulatory compliance and manufacturing change management.
- Develop, review, approve, and execute validation strategies and deliverables for equipment qualification, decommissioning, process validation, cleaning validation, and cleanroom qualification.
- Provide quality and compliance oversight for equipment purchases, relocations, and decommissioning.
- Evaluate regulatory impact of facility modifications, equipment relocations, and process changes.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
