Sterilization Quality Manager

About the role

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Primary Duties: - Drive compliance with Good Manufacturing Practices of the Sterilization plant. By knowing the GMP's and verifying their compliance through internal processes, to ensure that all activities are aligned to the requirements of national and corporate regulations and customer needs. - Manages the sterilization quality system and quality personnel, including lot release and quality engineering. - Coordinates and supervises the activities of the Quality Assurance and Quality Control Area of the sterilization plant. Verifying the fulfillment of procedures with which the quality of the product is assured in the sterilization process. - Management and control of material resources for the Quality department, in addition to preparing and controlling the budget assigned to the area under its responsibility. Generating an annual budget for the Quality Sterilization area based on the activities and monitoring and reporting to the cost area, to keep track of activities vs. expenses. - Provides training in the areas of Quality Assurance and Quality Control to the personnel in the organization, to guarantee effective monitoring and implementation of the quality procedures. - Support the validation of Sterilization Cycles in accordance with international and corporate standards. Following up on the current regulations and changes that are generated in this in addition to compliance with internal procedures to ensure the quality of the products processed in the sterilization plant. Promotes a safe work environment. Provides recommendations on maintaining the safety of the work environment. Follows safety procedures. Participates in Environment Health and Safety (EH&S) programs. Initiates a corrective action whenever a hazard is identified. - Participates in Continuous Improvement Projects related tasks as required. - Authority to stop any process that is creating quality issues. - Authority to release sterilized material to continue with next process or detain product or suspect or defective materials. - Other duties as required to support the needs of the business QMS responsibilities : - Creates, maintains, and improves quality control and assurance systems based on current local, international, and corporate regulations, developing, and implementing standard operating procedures, records, and specifications, to guarantee compliance with local, international, and corporate standards for customer satisfaction, including approving standard operating procedures that allow the correct statistical analysis of results and indicators performance. - Responsible for the final approval of protocols for the Qualification of areas, equipment, and services and their control plans, as well as the validation of processes, including both laboratories (microbiology and chemical) and production to guarantee their reproducibility. - Ensures the proper functioning of the quality system of corrective and preventive actions (CAPA), as well as customer complaints and quality alerts from the Sterilization plant including root cause investigation. - Attends internal and external audits for the Sterilization process carried out by clients and health authorities, as well as to resolve non-conformities and observations derived from them. Follow up on the closure of events and non-conformities that put the sterilization process at risk to ensure complete customer satisfaction. Education and Experience: Bachelor's in engineering, Biological Sciences, Chemistry or related areas; master's degree desirable. - CQM (Certified Quality Manager) preferred - Training evidence in ISO11135 (internal or external) - Preferred seven (7) years of experience in Quality Systems Management following ISO13485. - Preferred seven (7) years supervisory or management experience of administrative personnel - Preferred five (5) years of experience supporting qualification of systems, areas, and equipment. - Preferred five (5) years of experience of Good Manufacturing Practices - Preferred five (5) years of experience leading Validation, Microbiological and Sterilization Processes following ISO11135 current version - Preferred five (5) years of experience in developing and maintaining Master Validation Plans - Preferred five (5) years of experience in analytical and statistical skills in the application of techniques such as, but not limited to, Risk Analysis, Design of experiments, Statistical sampling - Experience in developing validation strategies according to local and internati

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