Sterilization Specialist
hace 3 semanas
A Day in the Life
At Medtronic, we rely on professionals like you to help us deliver high-quality products that make a difference in people's lives. As a Sterilization Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and safety.
Responsibilities:
- Work independently with guidance and direction from senior members of the team and manager.
- Assure all quality requirements are in compliance with regulations and product specifications.
- Provide understanding of the audit process including types of audits, planning, preparation, execution and follow-up.
- Perform, coordinate, execute and summarize all areas of sterilization validation (EO, radiation, steam and chemical sterilization).
- Support the execution of sterilization validation cycles for new products.
- Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations.
- Support internal and external audits.
- Prepare written responses to regulatory questions.
- Review engineering change orders.
- Support in the resolution of non-conformances and implement corrective action.
- Work with facility maintenance and other departments for any Sterilizer and CEA improvement/corrective activities.
- Participate in special projects as assigned.
- Reviews change control notifications for impact to sterilization/microbial testing.
- Actively involved with purchasing department for microbiological technical expertise in the selection and certification of component vendors.
- Assuring that the Microbiology / Sterilization function is maintained per industry standards.
- Bachelors degree required
- Minimum of 4 years of relevant experience
- Advanced English
- Thorough knowledge of fundamental microbiology principles and bacterial lethality.
Requirements:
- Must Have:
Bachelors degree required
Minimum of 4 years of relevant experience
Advanced English
Thorough knowledge of fundamental microbiology principles and bacterial lethality. - Nice to Have:
-
Sterilization Specialist
hace 1 mes
Tijuana, Baja California, México Medtronic A tiempo completoCareers that Transform LivesA Day in the LifeAs a Sterilization Specialist at Medtronic, you will play a critical role in ensuring the quality and safety of our products. Your responsibilities will include:• Working independently with guidance and direction from senior members of the team and manager to develop, implement, and maintain sterilization...
-
Sterilization Process Specialist
hace 1 semana
Tijuana, Baja California, México Stryker Professional Latin America, S. DE R.L. DE C.V. A tiempo completoStryker Professional Latin America, S. DE R.L. DE C.V. is seeking a skilled Sterilization Process Specialist to join our team in Mexico.The estimated salary for this role is $120,000 - $180,000 per year, depending on experience and qualifications.About the RoleWe are looking for a highly motivated and experienced Sterilization Process Specialist to lead our...
-
Sterilization Specialist
hace 5 días
Tijuana, Baja California, México Corza Medical A tiempo completoJob DescriptionAt Corza Medical, we are seeking a highly skilled Sterilization Engineer to spearhead our sterilization strategy and ensure the highest standards of quality in our medical devices.About the RoleThis is a full-time position that requires strong knowledge of quality management systems, particularly in sterilization and microbiology. The...
-
Sterilization Specialist Ii
hace 3 semanas
Tijuana, Baja California, México Medtronic A tiempo completo**Career Overview**A career as a Sterilization Specialist II at Medtronic offers the opportunity to contribute to the development and implementation of sterilization processes that impact patient lives. As a key member of the team, you will apply scientific principles and technical expertise to ensure the highest standards of quality and safety in our...
-
Sterilization Quality Assurance Specialist
hace 1 mes
Tijuana, Baja California, México Flex A tiempo completoAt Flex, we're committed to delivering innovative products that improve the world. To support our extraordinary teams, we're looking for a Sterilization Quality Assurance Specialist to join our team in Tijuana.Reporting to the Quality Manager, this role involves:Key Responsibilities:Develop and initiate procedures for sterilization release and...
-
Senior Sterilization Specialist
hace 2 semanas
Tijuana, Baja California, México Medtronic A tiempo completoJob SummaryWe are seeking a highly skilled Sterilization Specialist to join our team at Medtronic. As a key member of our Quality team, you will be responsible for ensuring the sterilization processes are properly maintained and validated, adhering to industry standards and regulatory requirements.About the RoleYou will analyze chemical, biological, or...
-
Senior EO Sterilization Specialist
hace 2 días
Tijuana, Baja California, México Stryker Professional Latin America, S. DE R.L. DE C.V. A tiempo completoEO Sterilization Process ExpertStryker Professional Latin America, S. DE R.L. DE C.V. is seeking a skilled Senior EO Sterilization Specialist to join our team in Mexico.About the RoleThis role is responsible for ensuring that products processed with Ethylene Oxide (EO) meet relevant regulatory requirements and standards for sterilization processes.Key...
-
Quality Engineer
hace 3 semanas
Tijuana, Baja California, México Carlisle Interconnect Technologies A tiempo completoJob SummaryCarlisle Interconnect Technologies is seeking a Quality Engineer - Sterilization and Environmental Specialist to develop and coordinate environmental and sterilization plans to comply with applicable regulations. This role will provide support on environmental and sterilization validations, including protocol development and report generation....
-
Quality Assurance Specialist
hace 2 semanas
Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoStryker Tijuana Operations is seeking a skilled Quality Assurance Specialist to join our team in Tijuana, Mexico. As a Quality Assurance Specialist - Sterilization Process, you will play a crucial role in ensuring compliance and maintenance of the Quality Management System (QMS) at our Stryker Sterilization facility.ResponsibilitiesEnsure adherence to FDA...
-
Sterilization Process Specialist
hace 7 días
Tijuana, Baja California, México Medtronic A tiempo completoAbout the RoleThis position plays a critical role in ensuring the quality and efficacy of sterilization processes within Medtronic.ResponsibilitiesIndependently perform tasks with guidance from senior team members and managers, utilizing technical expertise to drive sterilization process improvements.Evaluate and ensure compliance with regulations and...
-
Quality Assurance Specialist
hace 2 semanas
Tijuana, Baja California, México Medtronic A tiempo completoCareers that Change LivesA Day in the Life of a Quality Assurance Specialist – Sterilization Validation:Responsibilities may include the following and other duties may be assigned.Ensure all quality requirements are in compliance with regulations and product specifications.Provide understanding of the audit process including types of audits, planning,...
-
Sterilization Quality Management Systems Specialist
hace 4 semanas
Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoAt Stryker Tijuana Operations, we are seeking a highly skilled Principal Quality Management Systems Specialist, Sterilization to join our team. This role is responsible for ensuring compliance and maintenance of the Quality Management System (QMS) at our Stryker Sterilization facility in Tijuana, Mexico.Key Responsibilities:Ensure compliance and maintenance...
-
Principal Quality Management Systems Specialist
hace 2 semanas
Tijuana, Baja California, México Stryker Group A tiempo completoJob SummaryWe are seeking a highly skilled Quality Management Systems Specialist to join our team at Stryker Sterilization. The successful candidate will be responsible for ensuring compliance and maintenance of our Quality Management System (QMS) at the Stryker Sterilization facility in Tijuana, Mexico. As a subject matter expert, you will provide guidance...
-
Senior Sterilization Quality Management Specialist
hace 3 semanas
Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoAt Stryker Tijuana Operations, we are seeking a Senior Sterilization Quality Management Specialist to ensure compliance and maintenance of our Quality Management System (QMS) at our sterilization facility in Tijuana, Mexico.The selected candidate will act as a subject matter expert on FDA Quality System Regulation, MDSAP regulations, ISO 11135, and ISO 13485...
-
Tijuana, Baja California, México Stryker A tiempo completoJob SummaryAs a Principal Quality Management Systems Specialist, Sterilization at Stryker, you will be responsible for ensuring compliance and maintenance of the Quality Management System (QMS) at the Stryker Sterilization facility in Tijuana, Mexico. You will act as a subject matter expert on FDA Quality System Regulation, MDSAP regulations, ISO 11135, and...
-
Senior Validation Specialist
hace 2 semanas
Tijuana, Baja California, México Centerpiece S. De R.L De C. V. A tiempo completoOverviewCenterpiece S. De R.L De C. V. is seeking a highly skilled Senior Validation Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the development, implementation, and execution of validation programs that meet regulatory requirements.About the RoleThis is a full-time position with a...
-
Tijuana, Baja California, México Carlisle Interconnect Technologies A tiempo completoJob OverviewCareer Opportunity for Environmental and Sterilization Quality Engineer at Carlisle Interconnect TechnologiesJob DescriptionWe are seeking a detail-oriented Environmental and Sterilization Quality Engineer to join our team at Carlisle Interconnect Technologies. As an Environmental and Sterilization Quality Engineer, you will be responsible for...
-
Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoJob Description:Stryker Tijuana Operations is seeking a highly skilled Quality Assurance Specialist to join our team in Mexico. As a key member of our sterilization operations team, you will be responsible for ensuring compliance and maintenance of our Quality Management System (QMS).Key Responsibilities:Ensure adherence to FDA Quality System Regulation,...
-
Senior Microbiologist
hace 4 semanas
Tijuana, Baja California, México Stryker Professional Latin America, S. DE R.L. DE C.V. A tiempo completoJob SummaryThe Staff Microbiologist will be primarily responsible for ensuring the compliance of products processed with Ethylene Oxide (EO) in Stryker are in accordance with relevant regulatory requirements and standards for Sterilization Process.Responsibilities and FunctionsDevelop and validate the ethylene oxide sterilization process in accordance with...
-
Tijuana, Baja California, México Carlisle Medical Technologies A tiempo completoJob DescriptionThis role is responsible for ensuring compliance with environmental and sterilization regulations in a medical manufacturing environment. The ideal candidate will have experience in validating processes, developing protocols and reports, and maintaining records.