Omnilife Manufacturing
We are a successful Mexican company dedicated to the production and distribution of dietary supplements, with presence in more than 19 countries worldwide.
As part of our growth and international expansion, we are opening our third manufacturing plant, located in Allen, Texas. Therefore, we are looking to add to our team a:
QUALITY SYSTEMS ENGINEER
(Ingeniero de Sistemas de Calidad)
Job Summary
Lead the implementation, maintenance, and continuous improvement of the Quality and Food Safety Management System at Omnilife Manufacturing’s U.S. plant, ensuring compliance with Food and Drug Administration (FDA) regulatory requirements and alignment with Good Manufacturing Practices (GMPs). Proactively identify and prevent food safety risks while ensuring the consistent manufacture of safe, high-quality food products.
Responsibilities
· Implement and maintain the Quality and Food Safety Management System in compliance with Title 21 of the Code of Federal Regulations (CFR), Parts 111 and 117, the Food Safety Modernization Act (FSMA), and Hazard Analysis and Risk-Based Preventive Controls (HARPC) to ensure legal and regulatory compliance and the manufacture of products that are safe for human consumption.
· Develop and implement a Food Safety Plan through hazard analysis and the establishment and management of preventive controls.
· Establish a verification and validation program for process preventive controls.
· Develop, maintain, and control Quality and Food Safety Management System documentation.
· Establish methodologies for managing quality and food safety deviations, including investigation, root cause analysis, corrective actions, and preventive actions, as applicable.
· Develop and maintain a supplier selection and approval program in accordance with quality and food safety requirements.
· Manage supplier audits and evaluations, including follow-up on findings and corrective actions.
· Develop, document, and maintain the plant’s traceability and product recall systems, including the establishment and maintenance of a crisis management procedure for product recalls.
· Establish and maintain training programs covering Good Manufacturing Practices (GMPs), Food Safety, Preventive Controls, HARPC, FSMA, and Quality and Food Safety Management System documentation.
· Coordinate and support FDA (Food and Drug Administration) inspections, as well as audits conducted by certification bodies, customers, and other applicable external parties within the scope of the Quality and Food Safety Management System.
· Develop and maintain an internal audit program to evaluate compliance and drive continuous improvement.
· Administer the Omnilife Manufacturing plant document management system to ensure the availability, proper retention, control, updating, and continuous improvement of quality and food safety documentation.
· Perform other related responsibilities and duties as required by the operational needs of the business.
Requirements:
· Bilingual in English and Spanish (Mandatory).
· Proficiency in Microsoft Word and Excel, particularly Excel.
· Education: Bachelor’s degree in Chemical Engineering, Food Science, Pharmaceutical Chemistry, Chemistry, or a related field.
· 3 to 5 years of experience with Quality Management Systems and Food Safety Management Systems.
· Knowledge and experience with Preventive Controls.
· Knowledge and experience with HARPC (Hazard Analysis and Risk-Based Preventive Controls).
· Knowledge of food safety regulations and Good Manufacturing Practices (GMPs).
· Knowledge of quality standards and regulations.
· Knowledge of auditing principles and practices.
Important:
Travel Requirement: Availability to travel to Mexico for the initial training required for the position.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Education:
Bachelor’s degree in Chemical Engineering, Food Science, Pharmaceutical Chemistry, Chemistry, or a related field (Required).
Experience:
· 3 to 5 years of experience with Quality Management Systems and Food Safety Management Systems.
· Knowledge and experience with Preventive Controls.
· Knowledge of food safety regulations and Good Manufacturing Practices (GMPs).
· Knowledge of quality standards and regulations.
Language:
- English (fluent, non-negotiable) (Required)
- Spanish (fluent, non-negotiable) (Required)
Ability to Commute: Allen, Tx
Work Location: In person
The physical demands described below are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions, in accordance with the Americans with Disabilities Act (ADA).
- Occasionally lift, carry, push, or pull loads weighing 10 to 15 kg (22 to 33 lbs.).
- Occasional exposure to noise and dust.
- Ability to sit and operate a computer, keyboard, and standard office equipment for extended periods.
- Ability to stand for 1 to 2 hours
- Comply with all company safety policies, use of personal protective equipment (PPE), and adherence at all times to OSHA requirements
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Omnilife is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.
Tipo de puesto: Tiempo completo
Sueldo: $75,000.00 - $77,500.00 al año
Beneficios:
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Pregunta(s) de postulación:
- ¿Estas legalmente autorizado para trabajar en Estados Unidos?
- ¿Puedes viajar a México durante una semana para capacitación inicial?
Idioma:
- Inglés y Español (Obligatorio)
Lugar de trabajo: Empleo presencial
