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Position Summary

The Environmental Health & Safety (EHS) Specialist is responsible for ensuring compliance with all applicable environmental, health, and safety regulations at the municipal, state, and federal levels. This position supports the development, implementation, and continuous improvement of programs designed to prevent workplace injuries, occupational illnesses, environmental incidents, and compliance risks.

The EHS Specialist will lead regulatory compliance activities, manage hazardous and biological waste programs, coordinate audits and inspections, deliver safety training, and promote a culture of safety and environmental responsibility throughout the facility. This role requires both strategic oversight and hands-on collaboration with Facilities, Operations, and cross-functional teams to drive compliance, corrective actions, and continuous improvement initiatives.

Key Responsibilities

Regulatory Compliance & EHS Programs

• Ensure compliance with applicable environmental, health, and safety regulations, including STPS requirements.

• Develop, implement, and maintain EHS policies, procedures, and programs.

• Maintain EHS permits, records, and compliance documentation.

Risk Management & Incident Prevention

• Conduct risk assessments, workplace inspections, and hazard evaluations.

• Lead incident, injury, and near-miss investigations and perform root cause analysis.

• Drive corrective and preventive actions to reduce workplace risks.

Training & Safety Culture

• Coordinate and deliver EHS training programs.

• Promote employee engagement and awareness through safety initiatives.

• Support the development of a proactive safety culture across the organization.

Environmental & Waste Management

• Manage hazardous, non-hazardous, and biological/infectious waste programs.

• Ensure proper handling, storage, transportation, and disposal of regulated materials.

• Monitor compliance with environmental and waste management regulations.

Audits, Emergency Preparedness & Continuous Improvement

• Coordinate internal and external audits, inspections, and regulatory visits.

• Maintain emergency preparedness and response programs, including drills and training.

• Partner with Facilities and Operations to implement EHS improvements and close audit findings.

Education and Experience

Required

• Bachelor’s degree in Environmental Health & Safety, Industrial Hygiene, Environmental Engineering, Occupational Health, or a related field.

• Minimum of 3–5 years of EHS experience within a manufacturing environment.

Preferred

• Experience in the medical device, pharmaceutical, healthcare, or other highly regulated manufacturing industries.

• Experience supporting ISO 14001, ISO 45001, and ISO 13485 management systems.

• Professional certifications related to Environmental, Health & Safety.

• Bilingual English and Spanish communication skills, both written and verbal.

Production QA Engineer

This position is responsible for evaluating, investigating, and maintaining the Quality Systems at the Tijuana facility, including Nonconforming Material Reports (NCMRs), Manufacturing Deviations, Change Control, Corrective and Preventive Actions (CAPA), and Part Number Generation.

Responsibilities:

• Maintain quality systems at the Tijuana plant, including NCMRs, CAPA, Change Orders (COR), and manufacturing deviations.
• Manage part number generation for semi-finished and finished products. Maintain the Master Validation Plan (MVP).
• Identify deficiencies and implement improvements within quality system processes, ensuring compliance with ISO 13485, FDA regulations (21 CFR Part 820/QMSR), COFEPRIS, and other applicable regulatory requirements.
• Support regulatory inspections conducted by the FDA and international regulatory agencies.
• Support rework activities and define inspection and quality controls.
• Collaborate in coordinating Quality Control resources across manufacturing processes and overtime requirements.

Requirements:

• Bachelor's degree completed.
• Minimum of 5 years of experience in Quality.
• Knowledge of Quality Engineering functions, principles, and best practices, including quality standards such as ISO 13485, 21 CFR Part 820, ISO 14971, and other relevant industry standards.
• Strong computer skills, including Microsoft Office (Word, Excel, PowerPoint).
• Advanced English proficiency.

Benefits:

• Weekly pay.
• Benefits in accordance with Mexican labor law.
• Savings fund.
• Major Medical Insurance (SGMM).
• Life insurance.
• Grocery vouchers.
• Additional benefits.

Location: Pacifico Industrial Park, Tijuana, Baja California, Mexico.

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