Fresenius Medical Care is the worlds leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day. Our plant in Malaysia manufactures concentrates and CAPD. In this position you will be legally responsible for managing our Enstek plant (145 employees) in Malaysia. In this position you will report into the VP MSC Cluster APAC.
Your goal is to achieve company objectives by ensuring on-time product delivery with the right quality, capacity, and cost. Lead the local management and development of the plant through efficient and effective employee management, organization, technology, planning, and controlling. Optimize work processes and implement lean six sigma methodologies, all while maintaining full compliance with regulations, laws, and Fresenius Medical Care corporate standards.
Tasks
Oversee all daily operations of the plant, ensuring adherence to quality, safety, and regulatory standards.
Develop and implement production plans, schedules, and workflows to meet production targets and customer demands.
Monitor and manage key performance indicators (KPIs) to drive operational efficiency and productivity.
Collaborate with senior management to develop and execute strategic plans for the plant.
Identify opportunities for process improvements, cost reductions, and innovation.
Lead initiatives to enhance production capabilities and expand manufacturing capacity.
Recruit, train, and develop a high-performing team of supervisors, technicians, and operators.
Foster a positive and inclusive work environment that encourages teamwork, collaboration, and continuous learning.
Conduct performance evaluations, provide feedback, and implement development plans for staff.
Ensure compliance with all relevant regulatory requirements, including FDA, GMP, and ISO standards.
Implement and maintain quality control systems to guarantee the highest standards of product quality.
Oversee audits, inspections, and certification processes.
Develop and manage the plant's budget, including labor, materials, and overhead costs.
Monitor financial performance and implement cost-saving measures without compromising quality or safety.
Prepare and present regular financial and operational reports to senior management.
Promote a culture of safety and ensure all safety protocols and procedures are strictly followed.
Conduct regular safety audits and risk assessments to identify and mitigate potential hazards.
Lead initiatives to minimize the plant's environmental impact and ensure compliance with environmental regulations.
Partner with the Environmental Health and Safety Manager to ensure comprehensive awareness and adherence to safety policies, fostering a secure workplace environment.
Ensure compliance with FMC Compliance Policy and all relevant global/local regulations, ensuring all employees adhere to applicable standards.
Act as the primary point of contact for internal and external stakeholders, including suppliers, customers, and regulatory bodies.
Build and maintain strong relationships with key stakeholders to support the plant's objectives and growth.
Profile
Your personality is characterized by a high level of drive, positive mindset and energy. You are an experienced plant leader, and you have excellent people management skills. You have an improvement mindset and sharp eye for details. You are pragmatic, process oriented and open for new ways of working.
Bachelors or Master degree in Engineering, Manufacturing, Business Administration, or a related field.
Minimum of 10 years of experience in manufacturing operations, with at least 5 years in a managerial role within the Medical Device/Pharma industry.
Proven track record of successfully leading and managing a manufacturing plant.
Proven track record in successfully restructuring, reorganizing, and implementing cost-cutting programs in a manufacturing plant.
In-depth knowledge of regulatory standards (FDA, GMP, ISO 13485) and a commitment to maintaining high-quality standards.
Proven experience with implementing Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
Strong knowledge of manufacturing processes, quality control, and regulatory requirements.
Excellent leadership and team management abilities, with a focus on developing and motivating staff.
Strong problem-solving skills and the ability to make data-driven decisions.
Exceptional communication and interpersonal skills, with the ability to engage effectively with all levels of the organization.
Solid understanding of financial principles and the ability to manage budgets and financial performance.
Experience in cost control, financial reporting, and implementing cost-saving measures.
Experience in managing audits, inspections, and certification processes.
Strong commitment to health, safety, and environmental management.
Experience in conducting safety audits and implementing risk mitigation measures
Excellent planning and organizational skills, with the ability to prioritize production and maintenance needs.
Adaptability and flexibility in dealing with changing priorities and situations.
Highly motivated, results-oriented, and driven individual.
High language proficiency in English (spoken & written) and one of the local languages.
