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 international regulations.

Knowledge and Skills:

Basic knowledge in chemicals and kinetic reactions.

• Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable.
• Knowledge of Ethylene Oxide sterilizer equipment operation
• Work experience with ERP systems: JDE or SAP
• Working knowledge of MS Windows environment software such as MS Office.
• Effective skills using analytical thinking, problem solving, risk management, interpersonal relationships, Statistical skills and data analysis; written and oral communication, and planning/organization.
• Experience in non-conforming investigations, Inspection plans and problem solving
• Ability to partner with a diverse group of people. This includes the ability to deal with ambiguity, being flexible, having interpersonal savvy to influence, and being receptive to feedback.
• The ability to train and provide feedback (positive and constructive) to co-workers
• Demonstrate ability to multi-task and prioritize work activities, with a sense of urgency/initiative
• Strong organizational and time management skills
• Excellent written and verbal communication to relay technical concepts and study requirements to non-expert stakeholders and to understand and translate complex technical requirements into clear actions for execution

Physical Demands:

Occasionally, the work requires carrying, lifting, pushing and pulling of heavy weight level of objects. In addition, occasionally requires standing. Frequently, the job requires walking, sitting, reaching, handling, fingering, talking, hearing, seeing (near/far) vision, visual color discrimination and seeing (depth perception).

Work Environment:

• Apply commonsense understanding to carry out detailed written or oral instructions. Manage stressful situations.
• The work is performed constantly inside the Ethylene Oxide sterilization building.
• Also, the work environment has noise (vibration), hazards exposures (electrical, burns and biomedical) and atmospheric conditions (fumes and odors).
• Partnering with a diverse group of people is expected. This includes the ability to deal with ambiguity, being flexible, having interpersonal savvy to influence, and being receptive to feedback.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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