JT371 - SR QUALITY ENGINEER
About The Position
Quality Consulting Group is seeking a Senior Quality Engineer to support work in the pharmaceutical, biotech, medical device, and manufacturing industries in Puerto Rico and the United States. The role focuses on establishing and maintaining quality standards and protocols for processing materials into partially finished or finished products, and on working with engineering and manufacturing teams to ensure those standards are applied. The position includes developing and maintaining inspection, testing, and evaluation methods; specifying inspection and testing equipment; conducting quality assurance tests; and analyzing product and material issues. It also involves ensuring corrective actions meet reliability standards and that documentation complies with applicable requirements. The engineer may work across design, incoming materials, production control, product evaluation and reliability, inventory control, or research and development, as related to product or process quality. Key areas include equipment and process validation, quality systems and change control, regulatory compliance, and manufacturing change management.
Requirements
- Bachelor’s or master’s degree in Mechanical, Industrial, or Electrical Engineering, or a related field; listed as preferred.
- Experience in FDA- or ISO-regulated manufacturing environments.
- Experience with 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 or second 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.
- Develop and implement methods and procedures for inspecting, testing, and evaluating product and production-equipment precision and accuracy.
- Design or specify inspection and testing mechanisms and equipment.
- Conduct quality assurance tests and perform statistical analysis of products or materials that do not meet required standards and specifications, including assessing costs and determining responsibility.
- Ensure corrective measures meet acceptable reliability standards and documentation complies with requirements.
- Support quality activities in areas such as design, incoming materials, production control, product evaluation and reliability, inventory control, and research and development.
- Work on equipment and process validation, quality systems and change control, regulatory compliance, and manufacturing change management.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
