Sterilization Quality Engineer
hace 7 meses
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.
Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Sterilization Quality Engineer located in Tijuana.
Reporting to the Quality Manager the Sterilization Quality Engineer’s role involves:
What a typical day looks like:
- Develops and initiates procedures for sterilization release and validation.
- Coordination and evaluation of non-conformant product disposition related with sterilization excursions.
- Support workers engaged in monitor sterilization metrics.
- Provide training to workers related with sterilization process.
- Review and analyze bioburden and dose audits data.
- Review and analyze endotoxin testing results.
- Coordinate and conduct sterilization validation process for ethylene oxide and radiation methods.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Determine appropriate validation, process controls and monitoring (e.g. dose audits, parametric release, process challenge device (PCD), residuals, etc.) are properly implemented to ensure Sterility Assurance Level (SAL). Ensure the process is documented in accordance with industry standards: ISO 11135, ISO 11137.
The experience we’re looking to add to our team:
- Advanced English
- Typically requires a bachelor’s degree,
- Able to use Office system: Word, Excel, Power point, etc.
- Communicate and escalate situations on time.
- Understand EO and radiation concepts.
- Material classification: Assess and classify product and process defects and nonconformities.
- Knowledge in Quality System concepts
What you’ll receive for the great work you provide:
- Pantry vouchers
- Saving Fund
- Christmas bonus
- Holiday bonus
- Medical Insurance
- Life Insurance
EM57
Job Category
Quality
**Required Skills**:
Optional Skills:
-
Sterilization Engineer
hace 4 días
Tijuana, México Flex A tiempo completoAt Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in...
-
Sterilization Engineer
hace 2 semanas
Tijuana, México Flex A tiempo completoThrough the collective strength of 170,000 team members across 30 countries and responsible, sustainable operations, Flex, a Fortune global 500 company, is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We welcome people of all backgrounds. A career with...
-
Sterilization Engineer
hace 7 meses
Tijuana, México Corza Medical A tiempo completo**Vacancy Name** - Sterilization Engineer **Location of Work** - Tijuana, Mexico **Employment Type** - Full Time Employee **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.- **Remarkable service** A seamless,...
-
Sterilization Quality Engineer
hace 7 meses
Tijuana, México Flex A tiempo completoFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the...
-
Sterilization Quality Control Specialist
hace 4 semanas
Tijuana, Baja California, México Carlisle Interconnect Technologies A tiempo completoJob DescriptionWe are seeking a skilled Sterilization Quality Control Specialist to join our team at Carlisle Interconnect Technologies. In this role, you will be responsible for ensuring the quality of sterilized products and developing plans to comply with regulatory requirements.Key Responsibilities:Develop and coordinate environmental and sterilization...
-
Environmental and Sterilization Quality Engineer
hace 7 meses
Tijuana, México Carlisle Interconnect Technologies A tiempo completoResponsibilities: - Develop and Coordinate Environmental and Sterilization Plans to comply with applicable regulations. - Provide support on Environmental and Sterilization Validations, including but not limited to the development of Protocols and Reports. - File, update, and maintain Environmental and Sterilization records in accordance with applicable...
-
Environmental and Sterilization Quality Engineer
hace 7 meses
Tijuana, México Carlisle Medical Technologies A tiempo completoDescripción y detalle de las actividades Responsibilities: - Develop and Coordinate Environmental and Sterilization Plans to comply with applicable regulations. - Provide support on Environmental and Sterilization Validations, including but not limited to the development of Protocols and Reports. - File, update, and maintain Environmental and Sterilization...
-
Quality Assurance Specialist for Sterilization Process
hace 4 semanas
Tijuana, Baja California, México Flex A tiempo completoSterilization Quality AssuranceFlex is seeking a highly skilled Sterilization Quality Assurance Specialist to join our team in Tijuana, Mexico. This individual will play a critical role in ensuring the quality of our sterilized products by developing and implementing procedures for sterilization release and validation.About the RoleThis position requires a...
-
Environmental and Sterilization Quality Engineer
hace 7 meses
Tijuana, México Carlisle Companies A tiempo completoMinimum Requirements: - Bachelor's degree on Microbiology, Biochemical Engineering, QFB, or similar - Experience in medical manufacturing environment conditions and controls - Knowledge Environmental/Sterilization process and applicable standards - Knowledge of ISO 13485:2016, CFR 21, Cofepris, and other applicable standards - Bilingual, English 80% -...
-
Tijuana, Baja California, México Carlisle Medical Technologies A tiempo completoJob Overview:We are seeking a highly skilled Environmental and Sterilization Quality Engineer to join our Quality team at Carlisle Medical Technologies.About the Role:This is a permanent, full-time position with a standard business schedule from Monday to Friday with regular working hours.No travel is required for this role.Main Responsibilities:Develop and...
-
Sterilization Validation Specialist
hace 5 días
Tijuana, Baja California, México Medtronic A tiempo completoAbout the Role\Exceptions with quality requirements are a major concern in our industry, and we need someone who can ensure all processes are compliant with regulations and product specifications. As a Sterilization Validation Specialist at Medtronic, you will work closely with senior members of the team and manager to assure that all quality requirements...
-
Quality Assurance Specialist
hace 2 meses
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,...
-
Senior Sterilization Operations Manager
hace 4 semanas
Tijuana, Baja California, México Corza Medical A tiempo completoRole OverviewWe are seeking a highly skilled Senior Sterilization Operations Manager to spearhead our sterilization strategy for the wound closure organization. This critical role ensures that all cleanroom and controlled environment rooms meet regulatory standards and daily practices support a relevant monitoring cadence.Key ResponsibilitiesDevelop and...
-
Sterilization Site Leader Role
hace 7 meses
Tijuana, México Stryker Corporation A tiempo completo**Sterilization Site Leader** **Reports To**: Senior Director, Sterilization Services **Position Summary**: The Sterilization plant leader is responsible for the safe and efficient operation of the sterilization facility. They source, recruit and oversee a team of employees, ensuring all safety and regulatory standards are adhered too and in place. They...
-
Microbiologist Specialist
hace 5 días
Tijuana, Baja California, México Medtronic A tiempo completoAbout the RoleWe are seeking a highly skilled Microbiologist Specialist to join our team. In this role, you will be responsible for ensuring all quality requirements are met in compliance with regulations and product specifications.ResponsibilitiesSome of the key responsibilities of this role include:Working independently with guidance from senior members of...
-
Senior Sterilization Specialist
hace 2 meses
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 Validation Specialist
hace 2 meses
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...
-
Quality Engineer
hace 1 semana
Tijuana, México TACNA OUTSET A tiempo completoReview systems and processes to develop continued improvements through data analysis. - Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing processes. - Analyzes and performs failure analysis (investigations) to non-conforming products. - Leads in the...
-
Sterility Assurance Specialist
hace 4 semanas
Tijuana, Baja California, México Avent, S. De R.L. De C.V. A tiempo completoAvent, S. De R.L. De C.V. seeks a highly skilled Sterility Assurance Specialist to join our team in Quality Assurance. As a key member of our quality team, you will be responsible for supporting the implementation of our Global Sterility Assurance Quality Operation program at our manufacturing sites.The successful candidate will have a B.S in Microbiology,...
-
Quality Engineer
hace 2 días
Tijuana, México Outset Medical A tiempo completo**Company Overview** Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally...