Koch Industries

Private conglomerate in energy and materials

Quality Control Engineer - Medical

Quality EngineeringConfirmed live in the last 24 hours

Full-timeNogales, Sonora, MexicoNo salary listedIn-person

About the Job

Requirements

A degree in Industrial Engineering, Manufacturing, Biomedical Engineering, or a related field.
Three years of experience in medical-product manufacturing processes.
Experience with validation of medical processes and products, including IQ, OQ, PQ, and TMV.
Knowledge of quality management systems under ISO 13485 and ISO 9001.
Intermediate-to-advanced English proficiency.

Responsibilities

Provide technical support and guidance for manufacturing processes involving cables and harnesses for medical devices.
Ensure compliance with quality and regulatory requirements applicable to medical products.
Lead and follow up on process and product validation activities, including IQ, OQ, PQ, and TMV.
Participate in the introduction and transfer of new products (NPI), ensuring regulatory compliance.
Coordinate quality investigations, root-cause analysis, and corrective and preventive actions (CAPA).
Facilitate multidisciplinary teams in problem-solving and process improvement.
Participate in internal, external, and customer audits.
Promote compliance with ISO 13485, ISO 9001, and corporate procedures.
Monitor quality indicators and support continuous-improvement initiatives.
Ensure manufactured products meet customer quality specifications, applicable regulatory requirements, and Quality Management System standards.
Facilitate multidisciplinary teams in problem-solving, continuous improvement, and compliance with ISO 13485 and ISO 9001 during medical-product manufacturing and transfer.
Support regulatory compliance, medical-product validations, product transfers, and new-product expansion in a highly regulated environment.

Desired Qualifications

Experience in cable and harness manufacturing.

Your Job

Asegurar que los productos manufacturados cumplan con las especificaciones de calidad del cliente, los requisitos regulatorios aplicables y los estándares del Sistema de Gestión de Calidad. Actuar como facilitador de equipos multidisciplinarios para la solución de problemas, mejora continua y cumplimiento de las certificaciones ISO 13485 e ISO 9001 durante la manufactura y transferencia de productos médicos.

Our Team

Garantiza el cumplimiento de los requerimientos regulatorios (ISO 13485), validaciones de productos médicos y soporte a transferencias y expansión de nuevos productos dentro de un entorno altamente regulado.

What You Will Do

Brindar soporte y orientación técnica en procesos de manufactura de cables y arneses para dispositivos médicos.
Asegurar el cumplimiento de los requisitos de calidad y regulación aplicables a productos médicos.
Liderar y dar seguimiento a actividades de validación de procesos y productos (IQ, OQ, PQ y TMV).
Participar en la introducción y transferencia de nuevos productos (NPI) garantizando el cumplimiento regulatorio.
Coordinar investigaciones de calidad, análisis de causa raíz y acciones correctivas/preventivas (CAPA).
Facilitar equipos multidisciplinarios para la solución de problemas y mejora de procesos.
Participar en auditorías internas, externas y de clientes.
Promover el cumplimiento de los requisitos establecidos en ISO 13485, ISO 9001 y procedimientos corporativos.
Monitorear indicadores de calidad y apoyar iniciativas de mejora continua.

Who You Are (Basic Qualifications)

Ingeniería Industrial, Manufactura, Biomédica o carrera afín.
3 años de experiencia en procesos de manufactura de productos médicos.
Experiencia en validaciones de procesos y productos médicos (IQ, OQ, PQ y TMV).
Conocimiento de sistemas de gestión de calidad bajo ISO 13485 e ISO 9001.
Inglés intermedio-avanzado.

What Will Put You Ahead

·Experiencia en manufactura de cables y arneses.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

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At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

About the Company

Koch Industries

Private conglomerate in energy and materials

Koch Industries is a large, private, diversified conglomerate that operates in energy, chemical processing, and manufacturing. It started from an innovation that turned heavy crude oil into gasoline and grew through long‑term investments rather than short‑term market moves. The company generates value by refining fuels and producing chemical products, and it operates Georgia-Pacific, a major maker of paper and building products. Its business model relies on reinvesting most earnings back into the company to fund steady, long‑term growth rather than paying out frequent dividends or seeking quick profits. Koch differentiates itself from many competitors by staying privately owned, which reduces pressure from public markets and enables longer‑range planning. The company’s goal is to build scale and durability across its holdings by sustainable, multi‑decade growth rather than rapid, episodic gains.

Company size: 5,001-10,000
Company stage: Growth Equity (Non-Venture Capital)
Total funding: $985.2M
Headquarters: Wichita, KS
Founded: 1940

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