Empleos actuales relacionados con Quality Engineer Iii, Design Assurance - Tecate - Teleflex
-
Supervisor, Quality Assurance
hace 6 días
Tecate, México NysonianSolutions Inc. A tiempo completo**Company Overview**Nysonian Inc. is an American conglomerate employing over 50 team members across 7 countries, with 1.3 million customers across industries. We have local operations in the USA and Canada, primarily focusing on e-commerce sales with brands in Travel, Health, and Fitness niches that are on the verge of becoming the next big thing in the...
-
Supervisor, Quality Assurance
hace 6 días
Tecate, México NysonianSolutions Inc. A tiempo completo**Company Overview** Nysonian Inc. is an American conglomerate employing over 50 team members across 7 countries, with 1.3 million customers across industries. We have local operations in the USA and Canada, primarily focusing on e-commerce sales with brands in Travel, Health, and Fitness niches that are on the verge of becoming the next big thing in the...
-
Sr. Quality Engineer
hace 3 semanas
Tecate, México Vtech A tiempo completoAs Vtech establishes new operations in our Mexico facility, the Quality Engineer will be an integral part of the core team responsible for setting up the overall facility including processes, employee training and ongoing support.The position reports directly to the Plant Manager and will have frequent interaction with senior management from the U.S....
-
Quality Engineer
hace 4 semanas
Tecate, México Rockwell Automation A tiempo completoRockwell Automation is a global technology leader focused on helping the world's manufacturers be more productive, sustainable, and agile.With more than 28,000 employees who make the world better every day, we know we have something special.Behind our customers - amazing companies that help feed the world, provide life-saving medicine on a global scale, and...
-
Quality Engineer
hace 3 semanas
Tecate, México Rockwell Automation A tiempo completoRockwell Automation is a global technology leader focused on helping the world’s manufacturers be more productive, sustainable, and agile. With more than 28,000 employees who make the world better every day, we know we have something special. Behind our customers - amazing companies that help feed the world, provide life-saving medicine on a global scale,...
-
Quality Engineer
hace 3 semanas
Tecate, México Rockwell Automation A tiempo completoRockwell Automation is a global technology leader focused on helping the world’s manufacturers be more productive, sustainable, and agile. With more than 28,000 employees who make the world better every day, we know we have something special. Behind our customers - amazing companies that help feed the world, provide life-saving medicine on a global scale,...
-
Sqe (Supplier Quality Engineer) - Foránea
hace 2 semanas
Tecate, México Teleflex A tiempo completoDescripción y detalle de las actividades - The Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of medical products. He/She will utilize Quality Engineering tools for the effective and efficient development and maintenance of...
-
Quality Engineer
hace 2 semanas
Tecate, México Z-Tronix A tiempo completoRESPONSIBILITIES:- Perform root cause analysis of quality issues, often using advanced problem-solving tools- Coordinate or independently recommend and implement cost effective permanent corrective actions either within the quality function or coordinating with other plant functions.- Continuously review and ensure compliance of data provided by hourly...
-
Process Quality Engineer
hace 6 días
Tecate, México Schlage de México, S.A. de C.V. A tiempo completoDescripción y detalle de las actividades **Main Objective**: Implement and monitor the quality system, support operations in solving problems affecting product quality, manufacturing, and area efficiency, and coordinate problem resolution across Allegion Baja plants. **Key Responsibilities**: - Implement projects to reduce waste and drive continuous...
-
Process Quality Engineer
hace 6 días
Tecate, México Schlage de México, S.A. de C.V. A tiempo completoDescripción y detalle de las actividades**Main Objective**:Implement and monitor the quality system, support operations in solving problems affecting product quality, manufacturing, and area efficiency, and coordinate problem resolution across Allegion Baja plants.**Key Responsibilities**:- Implement projects to reduce waste and drive continuous...
Quality Engineer Iii, Design Assurance
hace 3 semanas
**About Teleflex Incorporated**
**Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
**Position Summary**:
As a member of a cross-functional team, the Quality Engineer III, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. The Quality Engineer III, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer III, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.
**Principal Responsibilities**:
1. Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
2. Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.
3. Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it's current risk profile. Support Clinical and Medical Writers in the analysis of available clinical data, as required.
6. Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
7. Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
8. Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.
10. Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development.
12. Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
13. Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
18. Contribute to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas related to those identified in this position description.
**Education / Experience Requirements**:
- B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered).
- 5 to 10 years of quality engineering or design assurance experience (preferably in the medical device industry).
**Specialized Skills / Other Requirements**:
- ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB).
- Strong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
- Proficient in MS Office, and Minitab or other statistical softwares.
- Strong organizational and time management skills to meet deadlines while managing multiple projects.
- Strong analytical and critical thinking skills.
- Proficient in technical report writing and review.
- Strong verbal and written communication skills.
- Foster a positive culture of growth, collaboration, and achievement across the organization.
LI-NR1
