JT370 - QUALITY ENGINEER II

Quality Consulting Group • Humacao, PR

53d

About The Position

Quality Consulting Group is seeking a highly motivated Quality Engineer II to contribute to pharmaceutical, biotech, medical device, and manufacturing operations in Puerto Rico and the USA. The role develops and maintains quality standards and protocols, partners with engineering and manufacturing teams to uphold those standards, and uses inspection, testing, and statistical analysis to assess product and production-equipment quality. The position also ensures corrective actions meet reliability expectations and that documentation complies with applicable requirements. Areas of focus 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. The engineer collaborates with cross-functional teams to improve manufacturing processes and develop solutions. Availability for first shift is required.

Requirements

• Bachelor’s or master’s degree in Mechanical, Industrial, Electrical Engineering, or a related field preferred.
• At least 2 years of related experience.
• Experience in FDA- or ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
• Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
• Proficiency with problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
• Experience with quality and business systems such as Minitab, JMP, Excel, Power BI, and SAP.
• Strong communication, collaboration, continuous improvement, and critical-thinking skills.
• Availability for first shift.

Nice To Haves

• Lean Six Sigma certification.
• Automation or programming experience.

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.
• Devise 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 perform statistical analysis to assess the cost of and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and documentation complies with requirements.
• Work in quality-related areas such as design, incoming materials, production control, product evaluation and reliability, inventory control, or research and development, as applicable.
• Collaborate with cross-functional teams to develop solutions and improve manufacturing processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level