Coordinate and implement all site activities related to Environment, Health, and Safety (EHS), including, but not limited to, programs, site equipment, metrics, written procedures, and employee training, to ensure compliance with all existing local and national EHS regulations, as well as ICU Medical's procedural policies and systems. Essential Duties and Responsibilities Provide a facilities management function for the site to ensure that the plant, equipment, and general facilities are maintained in good order, proper repair, and efficient operation to meet medical device manufacturing demands. Ensure that planned maintenance activities for the building, building services equipment, and facilities are effectively implemented. Lead and coordinate a team of facilities and maintenance technicians. Support the site coordinator and site teams with projects and initiatives under EHS responsibility and act as the site safety officer in accordance with corporate guidelines. Maintain site security to protect Smiths Medical employees, visitors, and intellectual property. Develop and implement, as required, site‑specific regulations, systems, or environmental health and safety education programs related to risk for Smiths employees (managers and staff) involving the workplace, home, and community. Train and engage the site safety committee, line supervision, and other employees with specific EHS responsibilities. "Walk the floor" to ensure two‑way communication with employees and supervision, providing advice, information, suggestions, and ideas to improve EHS issues and practices, and ensuring that behavior‑based safety is part of working practices. Act as a resource for site EHS teams (fire wardens, spill team, emergency response team, Safety Committee, etc.) and site management. Coordinate and/or provide EHS training to educate employees on safety policies, EHS regulations, good practices, and procedures. Ensure the site has required land‑use permits and EHS permits in accordance with local planning controls. Coordinate site information to submit permit applications as necessary. Examine plans and specifications for new machinery, equipment, or facility proposals to determine if all EHS hazards and risks have been identified, and that precautions, safeguards, and controls (engineering, procedural, and administrative) have been established to eliminate, minimize, or control risk to the environment, people, and the company in accordance with company procedures. Help identify site‑specific EHS compliance issues, hazards, risks, and metric trends, and provide recommendations to mitigate risk to the environment, people, and the company, focusing on risk assessment and change management in work areas, tasks, and processes. Develop action plans to address identified issues in a timely manner. Re‑evaluate EHS hazards and risks when significant changes occur in work areas, processes, tasks, or work equipment (including changes in the frequency or duration of risk exposure) and changes in regulations or procedures. Conduct or organize site audits to identify potential hazards and ensure compliance with EHS regulations, company policy, property protection, and security. Act as the site representative for external EHS management systems and compliance audits. Conduct or organize all necessary risk assessments required by EHS legislation, including fire risk assessments, work area, work tasks, hazardous substances use, personal protective equipment, and environmental aspects and impact analysis. Implement good incident prevention and loss control practices for environmental health and safety to incorporate into site processes and procedures, including contractors working under site control procedures. Organize or conduct and analyze H&S sampling for employee exposure. Organize or conduct environmental sample collection for site emissions or suspected impacted materials, water, or soil when appropriate or required by legislation. Assist in the investigation of EHS incidents to minimize recurrence and ensure compliance with accident reporting regulations and company policy. Evaluate technical and scientific publications related to environmental health and safety management and participate in related professional organization activities to update knowledge on EHS developments. Ensure the hiring, evaluation, and development of direct reports; manage the selection training, development, evaluation, and feedback processes within the department to ensure employee motivation and retention. Design, agree upon, and develop succession planning opportunities at all levels with key personnel. Utilize the site's planned maintenance system to ensure that plant and equipment building services comply with regulatory requirements. Recommend a capital replacement program and raise capital expenditure requests (CAPEX) to improve efficiency and reduce site operating costs. Establish service contracts with suppliers and landlords to maintain the facilities. Ensure that site fire protection systems meet Global Insurance requirements. Set up and maintain site hygiene to meet medical device manufacturing requirements. Implement a planned maintenance system for the site, utilizing Total Productive Maintenance (TPM) and visual management techniques. Maintain a fully documented maintenance system to comply with regulatory requirements, including FDA 21 CFR Part 820. Ensure process validation activities support the PM (Preventive Maintenance) system on site. Take personal responsibility to avoid accidents and injuries. Comply with all safe work practices and organizational policies and procedures. Contribute to achieving objectives regarding Safety and the Environment. Comply with all requirements of the Quality System for the assigned product/process following applicable instructions, procedures, and policies. Notify any event that could jeopardize product/process quality. This position is required to ensure compliance of Company operations with all applicable laws, regulations, standards, good business practices, and documented company procedures (including knowledge of all government occupational health and environmental standards, regulations, and statutes). Engage others, promote, and participate in environment, health, and safety initiatives, focusing on continuous improvement. Work on special projects as assigned. Knowledge and Skills Trained as an ISO‑14001:2004 internal lead auditor. Experience as an internal leader in ISO 19011 and ISO 14000. Strong computer skills required, including Windows, Word, Excel, Access, and PowerPoint. Fluency in English and Spanish language skills. Certification as an ISO‑14001 Lead Auditor or similar related fields. Knowledge of federal, state, and municipal government laws, rules, regulations, and filings, and their application in health and environmental areas. Knowledge of international agreements. Technical problem solving and root cause analysis (RCA). Communication capabilities at all levels. Minimum Qualifications, Education, and Experience A university‑level degree in a related field and/or a Health and Safety/Environmental qualification plus equivalent experience is required. Previous work experience in medical device or pharmaceutical manufacturing. +10 years of experience in ISO 14001 and Medical Device Regulations (CFR 820, ISO13485, NOM241) +10 years of experience in maintaining environmental management systems. Proven experience in EHS, site services, utilities, and waste management, along with knowledge gained within a manufacturing environment, is required. Proven environmental compliance and control experience. Preference will be given to candidates with professional health, safety, and environmental qualifications. This is largely a sedentary role. This work takes place in a professional office environment and routinely uses standard office equipment. While performing the duties of this job, the employee may be required to sit or stand for long periods of time. Must be able to occasionally move and lift objects up to 25 pounds. Typically requires travel 5% to 20% of the time. #J-18808-Ljbffr
Senior Hse And Facilities Manager
ICU MEDICAL
Tijuana, Tijuana
Publicado hace 4 días
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