Senior Quality Systems Specialist
hace 4 semanas
Job Summary
We are seeking a highly skilled Senior Quality Systems Specialist to join our team at Stryker Tijuana Operations. As a key member of our quality team, you will be responsible for ensuring compliance and maintenance of our Quality Management System (QMS) at our sterilization facility in Tijuana, Mexico.
Key Responsibilities
- Ensure compliance and maintenance of the QMS at the Stryker Sterilization facility in Tijuana, Mexico.
- Act as a subject matter expert on FDA Quality System Regulation, MDSAP regulations, ISO 11135, and ISO 13485 standards. Support internal and external quality system audits, ensuring compliance.
- Lead investigations, manage non-conformances (NC), and perform CAPA review and approval tasks.
- Develop and maintain Power BI dashboards related to the QMS, in collaboration with Corporate RAQAC analytics.
- Train new QMS specialists on Stryker's procedures and sterilization quality management systems.
- Plan and execute internal audits based on the processes of the sterilization organization.
- Coordinate and provide applicable compliance training.
- Interpret and apply regulations such as FDA, ISO, MDSAP, EU MDR, and Stryker policies.
- Conduct trend analysis on key performance indicators and organize Management Reviews.
Requirements
- BS in a science, engineering, or related discipline. Master's degree or equivalent preferred.
- 7+ years of similar experience in a high regulated industry.
- Experience with the following regulations/standards preferred: 21 CFR Part 820, MDSAP, ISO standards (e.g., ISO 13485:2016, ISO 14971:2019) and ISO 11135 – Ethylene Oxide Sterilization.
- Solid knowledge of manufacturing processes, statistical techniques, environmental controls and basic Regulatory requirements for medical devices.
- Strong knowledge of quality management system processes (NC/CAPA, Complaints Handling, Management Review, Quality Planning, etc.).
- Bilingual (English & Spanish).
- Strong communication, project management and influencing skills.
- Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
- Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.
- Utilize proper software to maintain project records, MS Office, SharePoint, Visio and Power BI.
Travel Percentage
10%
-
Senior Systems Maintenance Specialist
hace 3 semanas
Tijuana, Baja California, México Infineon Technologies A tiempo completoJob Title: Senior Systems Maintenance SpecialistInfineon Technologies seeks a highly skilled Senior Systems Maintenance Specialist to join our team in Wastewater Treatment. As a key member of our maintenance team, you will be responsible for ensuring the optimal performance of our wastewater management systems.Key Responsibilities:Wastewater management...
-
Management Systems Quality Assurance Specialist
hace 3 semanas
Tijuana, Baja California, México Ericsson A tiempo completoAbout this opportunity:We're seeking a highly skilled Management Systems Quality Assurance Specialist to join our team at Ericsson. As a key member of our organization, you will be responsible for implementing and maintaining our quality management systems, ensuring compliance with international standards such as ISO 9001, ISO 45001, and ISO 14001.In this...
-
Senior Quality Assurance Specialist
hace 4 días
Tijuana, Baja California, México Thermo Fisher Scientific A tiempo completoJob SummaryWe are seeking a Senior Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a key member of our quality assurance department, you will be responsible for ensuring the highest level of quality in our products and services.About the RoleThe Senior Quality Assurance Specialist will be responsible for:Conducting visual...
-
Senior Quality Assurance Specialist
hace 3 semanas
Tijuana, Baja California, México Stryker Corporation A tiempo completoAbout the Role:The Senior Quality Assurance Specialist will play a critical role in ensuring the maintenance of the quality system to deliver products that meet customer specifications and applicable regulatory requirements. This position requires a detail-oriented individual with a passion for quality and a strong understanding of quality systems and...
-
Senior Quality Assurance Specialist
hace 2 semanas
Tijuana, Baja California, México Enovis A tiempo completoJob Summary: We are seeking a Senior Quality Assurance Specialist to join our team at Enovis Corporation. The ideal candidate will have a strong background in quality assurance and a passion for developing and implementing quality systems.Key Responsibilities:Design and implement quality assurance protocols and methods for processing materials into partially...
-
Senior Quality Systems Manager
hace 3 semanas
Tijuana, Baja California, México EnerSys Delaware Inc. A tiempo completoEnerSys, a global leader in stored energy solutions, seeks a Senior Quality Systems Manager to lead the establishment and improvement of its quality management system.Job PurposeThis role promotes a culture of quality and continuous improvement throughout the plant, ensuring compliance with industry standards and regulations.Essential Duties and...
-
Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoJob Title: Principal Quality Management Systems Specialist, SterilizationWork Flexibility: OnsiteJob SummaryStryker Tijuana Operations is seeking a highly skilled Principal Quality Management Systems Specialist to join our team. As a key member of our quality management team, you will be responsible for ensuring compliance and maintenance of the Quality...
-
Senior Manager Quality Systems
hace 4 semanas
Tijuana, Baja California, México Infineon Technologies A tiempo completoAs a Senior Manager Quality Systems at Infineon Technologies, you will be responsible for ensuring the site's quality management system's compliance to customer, statutory, regulatory, and international standards. This includes assessing manufacturing readiness of new product designs, change control of existing product and process designs, and leading...
-
Senior Quality Assurance Specialist
hace 7 días
Tijuana, Baja California, México Medtronic A tiempo completoAbout the RoleWe are seeking a skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality engineering team, you will be responsible for developing and implementing quality standards and protocols for processing materials into partially finished or finished products.ResponsibilitiesDevelop, modify, apply, and maintain quality...
-
Senior Quality Assurance Specialist
hace 4 semanas
Tijuana, Baja California, México Eaton A tiempo completoEaton's AER FED Fluid Electrical Distribution division is seeking a Senior Quality Assurance Specialist to execute the defined Strategic Quality Plan.**Key Responsibilities:**Align resources and evaluate their effectiveness to define actions to improve performance and exceed expectations. Drive continuous improvement in quality using the Eaton Business...
-
Senior Manager Quality Systems
hace 3 semanas
Tijuana, Baja California, México Infineon Technologies A tiempo completoJob Summary:As a Senior Manager Quality Systems at Infineon Technologies, you will be responsible for ensuring the site's quality management system's compliance to customer, statutory, regulatory, and site requirements. This includes assessing manufacturing readiness of new product designs, change control of existing product and process designs, and leading...
-
Senior Manager Quality Systems
hace 4 semanas
Tijuana, Baja California, México Infineon Technologies A tiempo completoJob Summary:As a Senior Manager Quality Systems at Infineon Technologies, you will be responsible for ensuring the site's quality management system's compliance to customer, statutory, regulatory, and site requirements. This includes assessing manufacturing readiness of new product designs, change control of existing product and process designs, and leading...
-
Quality Systems Senior Manager
hace 3 semanas
Tijuana, Baja California, México Infineon Technologies A tiempo completoJob DescriptionAs a Senior Manager Quality Systems at Infineon Technologies, you will be responsible for ensuring the site's quality management system's compliance to customer, statutory, regulatory, and international standards. Your key responsibilities will include:Main ResponsibilitiesQuality Management System Compliance: Ensure the site's quality...
-
Senior Manager Quality Systems
hace 4 semanas
Tijuana, Baja California, México Infineon Technologies A tiempo completoJob SummaryWe are seeking a highly skilled Senior Manager Quality Systems to join our team at Infineon Technologies. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality in our products and processes.Key ResponsibilitiesUpdate and maintain the site's Quality Management System and the Management...
-
Quality Management Systems Specialist
hace 3 semanas
Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoJob SummaryStryker Tijuana Operations is seeking a highly skilled Quality Management Systems Specialist to join our team. As a key member of our sterilization facility, you will be responsible for ensuring compliance and maintenance of our Quality Management System (QMS).Key ResponsibilitiesEnsure compliance and maintenance of the QMS at the Stryker...
-
Senior Quality Assurance Specialist
hace 4 semanas
Tijuana, Baja California, México Enovis A tiempo completoJob Summary:As a Senior Quality Assurance Specialist at Enovis, you will conduct complex quality analysis and testing of our quality control program, identifying areas for improvement and recommending changes to ensure the highest quality standards. You will also analyze customer claims, prepare reports on rejected or defective products, and assist in the...
-
Quality Systems Director
hace 4 días
Tijuana, Baja California, México Infineon Technologies A tiempo completoJob DescriptionWe are seeking an experienced Quality Systems Director to join our team at Infineon Technologies.About the RoleThis is a senior leadership position that oversees the development, implementation, and maintenance of our quality management system. The successful candidate will have a proven track record in quality management systems, specifically...
-
Senior Quality Systems Manager
hace 4 semanas
Tijuana, Baja California, México Medtronic A tiempo completo**Quality Leadership Role**Medtronic seeks a seasoned Quality Systems Manager to oversee the development and maintenance of quality programs, systems, processes, and procedures. This role ensures compliance with policies and standards, and provides expertise in interpreting policies, regulations, and internal guidelines.**Key Responsibilities:**Provide...
-
Senior Quality Management Systems Coordinator
hace 7 días
Tijuana, Baja California, México Autoliv Mexico A tiempo completoJob Title: Senior Quality Management Systems CoordinatorLocation: Autoliv MexicoCompany OverviewAutoliv is a leading global automotive safety supplier. We strive to be the best and improve lives by saving people from accidents.About the RoleWe are seeking a motivated and experienced Senior Quality Management Systems Coordinator to join our team in Autoliv...
-
Senior Quality Assurance Specialist
hace 4 semanas
Tijuana, Baja California, México Vertiv A tiempo completo**Job Summary**We are seeking a highly skilled Senior Quality Assurance Specialist to lead our internal audit program and ensure compliance with our Quality Management System. The ideal candidate will have a strong background in quality management, excellent communication skills, and the ability to work independently.**Key Responsibilities**Develop and...