Senior Quality Engineer

Location: Rancho Dominguez, California, United States

Company

hirify.global operates a manufacturing facility supported by quality, engineering, operations, supply chain, and customer quality functions.

What you will do

• Lead quality investigations, root cause analysis, CAPA activities, risk assessments, and change management.
• Perform FMEA, Gauge R&R studies, statistical evaluations, process control, testing, validation, and equipment qualifications.
• Develop quality and inspection plans, procedures, work instructions, specifications, and documentation for manufacturing control points.
• Monitor metrology and calibration activities and evaluate the effectiveness of corrective actions.
• Investigate customer complaints, product and raw-material nonconformances, and supplier quality issues.
• Participate in ISO, internal, customer, and other quality audits while partnering with engineering, manufacturing, marketing, customers, and suppliers.

Requirements

• Bachelor’s degree in Engineering or Life Science.
• 7+ years of Quality Engineering and/or Manufacturing Engineering experience.
• Working knowledge of ISO 9001 quality systems and/or FDA 21 CFR 820 regulations.
• Experience with quality planning, CAPA, quality auditing, root cause analysis, statistical data analysis, and technical investigations.
• Strong verbal, written, interpersonal, technical, and administrative communication skills.
• Ability to work in a laboratory environment, handle potential hazardous-material exposure, and lift or move up to 25 pounds.

Nice to have

• ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, or Lead Auditor certification.
• Experience with MasterControl or a comparable eQMS platform.
• Experience with filtration products, single-use technologies, medical devices, biologics, or pharmaceutical manufacturing.

Culture & Benefits

• Full-time position supporting a cross-functional manufacturing organization.
• Occasional travel may be required based on business needs.
• Opportunity to contribute to continuous improvement, product quality, risk reduction, and customer satisfaction.