Senior Quality Engineer (Medical Devices)

Company

hirify.global is a global specialty materials manufacturer producing engineered components and solutions for filtration, healthcare, hygiene, packaging, and other industrial markets.

What you will do

• Act as the primary quality contact for customers in the medical devices, healthcare, and hygiene sectors.
• Lead investigations of customer complaints, claims, and non-conformities using 8D, root cause analysis, and CAPA.
• Coordinate product, process, supplier, raw material, specification, and customer-requirement changes, including risk assessment and validation.
• Plan and participate in customer audits, manage findings and corrective actions, and support customer qualification and supplier approval.
• Drive continuous improvement by analyzing quality trends, customer feedback, performance data, and process capability.
• Support product development, qualification, validation, commercialization, and quality planning activities.

Requirements

• Bachelor’s degree in engineering, quality management, materials science, or a related technical discipline.
• At least 5 years of experience in customer quality, quality engineering, or quality assurance in manufacturing or industrial environments.
• Experience with regulated industries such as medical devices, healthcare, hygiene, or personal care.
• Strong knowledge of 8D problem solving, root cause analysis, CAPA, FMEA, statistical analysis, and risk assessment.
• Knowledge of EDANA standards, ISO 9001, quality management systems, customer-specific requirements, and audit expectations.
• Spanish at advanced or native level and professional English proficiency, written and spoken, are required.

Nice to have

• Familiarity with APQP, PPAP, MSA, SPC, and IATF 16949 principles.
• Additional language skills.

Culture & Benefits

• Strategic customer-facing quality work with significant business impact.
• Direct interaction with leading medical, healthcare, and hygiene customers.
• Opportunities to lead improvement projects, customer quality initiatives, and audit activities.
• International exposure and professional growth opportunities.
• Collaborative, innovative, and quality-driven work environment with competitive employee benefits.