Quality Manager
hace 2 días
**Primary Location **: Mexico-Baja California Norte-Mexicali
**Description**:
**JOB SUMMARY**:
This position is responsible for providing leadership and is assigned the authority to implement, coordinate and monitor the facility’s Quality System as it pertains to contract sterilization of medical devices. Acts as the facility’s Quality Representative, ISO Management Representative, and lead Quality System contact for all activities related to the facility as directed by the Director Sterility Assurance with a commitment towards quality, accuracy, and process improvement.
1.Has authority and responsibility to represent the facility on all quality matters pertinent to the Quality Management System as established through customer and regulatory requirements as well as organizational quality policies and procedures.
2. Implements and communicates new or revised Quality System/Regulatory Compliance policies and procedures.
3. Ensures that QSR and ISO regulations are adhered to. Maintains a working knowledge of regulations and establishes a monitoring program that responds to audit activity in a constructive manner.
4.Ensures that all processing records are in compliance with processing specifications and Quality Systems/Regulatory Compliance requirements prior to product release. Has authority and responsibility to withhold release approval for customer product not meeting acceptance criteria. Should a question arise regarding product release or in regards to the quality of the product, service provided or regulatory issue, the issue will be discussed through appropriate management channels, ultimately to be brought before the Director Sterility Assurance for resolution.
5.Ensures the customer processing specifications are current and readily available to the facility production staff. 6. Ensures process control through review of operations, calibration, maintenance documents. Ensures that record keeping requirements are met and that good documentation practices are followed. In addition, reviews and maintains instrument calibration and qualification documentation to ensure tests are performed according to approved procedures and schedules with acceptable results. 7.Oversees that requirements are met on a continuous basis for sample transmittal and testing, as applicable.
8.Works with plant management to identify root cause and implements corrective actions as required due to process deviations, complaints, SCARs, CAPAs and external / internal audits. Oversees facility-training program in response to procedural changes, policy changes and improvement activities.
9.Facility Quality representative during customer and regulatory audits. Provides leadership and assistance during audits to meet customer and regulatory requirements and ensure that recommendations and corrective actions are appropriate as well as efficiently acted upon and documented. 10.Communicates with customer about all aspects of requirements during validation planning and execution. Oversees and coordinates validation program. Prepares validation protocols and final reports if requested by customers. 11.Oversees the maintenance of the facility supplier/vendor program. 12. Monitors and reports trending and data relative to Quality System and makes recommendations for improvements as well as establishes implementation plans. Generats and communicates periodic quality report as defined in QMS procedures 13.Provides leadership, manages, monitors, and mentors Sterilization Specialists to ensure effective performance and continual growth and development. Develops a positive learning environment, and encourages teamwork among all employees through consistent demonstration of leadership ability. 14.Supports a safe, clean and secure working environment by supporting procedures, rules and regulations; supports and participates in plant safety committees. Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized. 15. Monitors and participates in internal audits activities at facility or company level. 16. Oversees the maintenance and destruction of historical Quality Documents and Customer Run records according to defined retention periods. 17. Responsible for testing and reading self-contained BI vials that are used in the sterilization process if required. 18. Maintains day-to-day Quality System operations striving for continuous improvement and cost reduction without compromising quality. 19. Make decisions regarding practices and processes as a technical resource for the facility regarding sterilization practices, and standards. 20. Resolves customer complaints, audit observations, concerns regarding quality processing, and practices.
**Qualifications**:
**Education**
BS Degree in scientific or engineering background or equivalent experience in Quality/Sterilization industry preferred. Master degree preferred.
A Minimum of five (5) years of experience in medical device
-
Quality Assurance Manager
hace 3 semanas
Mexicali, Baja California, México Garrett Advancing Motion A tiempo completoWe are seeking an experienced Quality Assurance Manager to join our team at Garrett Advancing Motion. In this role, you will be responsible for leading quality initiatives and ensuring that our manufacturing processes meet the highest standards.
-
Quality Assurance Manager
hace 1 mes
Mexicali, Baja California, México Vertiv Co. A tiempo completoJob SummaryWe are seeking an experienced Quality Assurance Manager to join our team at Vertiv Co. in a challenging and rewarding role that offers the opportunity to make a significant impact on our organization.About the RoleThis position is responsible for ensuring the quality of our products and services, identifying areas for improvement, and implementing...
-
Quality Assurance Manager
hace 3 semanas
Mexicali, Baja California, México North American Production Sharing A tiempo completoAbout North American Production SharingWe are a leading production sharing company, and we're looking for a skilled Quality Assurance Manager to join our team.Job Summary:The Quality Assurance Manager will be responsible for ensuring that our quality systems meet the highest standards, including ISO 9000 certification. This is a challenging role that...
-
Quality Assurance Manager
hace 3 semanas
Mexicali, Baja California, México Chromalloy A tiempo completobody {font-family: Arial, sans-serif;}h1 {color: #00698f;}h2 {color: #008000;}p {margin-bottom: 10px;}Quality Assurance ManagerAt Chromalloy, we are seeking a highly skilled Quality Assurance Manager to lead our quality function. The successful candidate will have a strong background in aerospace or industrial gas turbine engine engineering.Key...
-
Quality Manager
hace 2 días
Mexicali, México Emprego MX A tiempo completoDescripción y detalle de las actividades : Responsible for the overall direction, coordination, and evaluation of the Quality System, ensuring product quality and process quality meet business, regulatory and customer objectives. Directly manages IQC (Incoming Quality Control), PQC (Process Quality Control) OQC (Outgoing Quality Control) processes and...
-
Quality Operations Manager
hace 6 días
Mexicali, México Intuitive A tiempo completo**Company Description**: Primary Function of Position: Manage Quality Operations for Intuitive’s manufacturing facility in the Mexicali location. Primary functional responsibilities include the areas of Preventive Maintenance Calibration (PMC), Product Release (DHR), and Continuous Improvement to ensure adherence to company quality standards. The Quality...
-
Quality Manager
hace 6 días
Mexicali, México Advanced Energy Industries, Inc A tiempo completoResponsible for the overall direction, coordination, and evaluation of the Quality System, ensuring product quality and process quality meet business, regulatory and customer objectives. Directly manages IQC (Incoming Quality Control), PQC (Process Quality Control) OQC (Outgoing Quality Control) processes and Supplier Quality to drive continuous...
-
Quality Manager
hace 6 días
Mexicali, México Emprego MX A tiempo completo**Descripción y detalle de las actividades** - : Responsible for the overall direction, coordination, and evaluation of the Quality System, ensuring product quality and process quality meet business, regulatory and customer objectives. Directly manages IQC (Incoming Quality Control), PQC (Process Quality Control) OQC (Outgoing Quality Control) processes and...
-
Quality Assurance Manager
hace 2 días
Mexicali, México TACNA KASA DEVELOPMENT A tiempo completoFully understands building materials and most certified us materials can read blueprints familiar with us building codes has a full understanding of quality assurance programs for construction can lead a team of 4-8 people, including buyers, receivers’ material handler qc inspectors. Good organizational skills can interact with a 3er party inspection...
-
Software Quality Assurance Manager
hace 2 meses
Mexicali, Baja California, México Ascotech, S.A. De C.V. A tiempo completoJob OverviewWe are seeking a highly skilled Software Quality Assurance Manager to lead our Quality Engineering department. This is a full-time, permanent position that requires excellent leadership and technical skills.Job SummaryThe Software Quality Assurance Manager will be responsible for planning, organizing, and directing all activities of the Quality...
-
Quality Manager Spectra Strip
hace 6 meses
Mexicali, México Amphenol TCS de México, S.A. de C.V. A tiempo completoDescripción y detalle de las actividades The Quality Manager role is to provide leadership and management of a multi-function team in the areas of safety, quality, Engineering, and cost performance over Spectra-strip product lines. The Quality Manager is accountable for the products being sent out meet consumer expectations. It’s their responsibility to...
-
Quality Manager Spectra Strip
hace 2 meses
Mexicali, México Amphenol TCS de México, S.A. de C.V. A tiempo completoDescripción y detalle de las actividades - The Quality Manager role is to provide leadership and management of a multi-function team in the areas of safety, quality, Engineering, and cost performance over Spectra-strip product lines. The Quality Manager is accountable for the products being sent out meet consumer expectations. It’s their responsibility to...
-
Quality Assurance Manager Hsio Copper
hace 1 mes
Mexicali, Baja California, México Amphenol Tcs De México, S.A. De C.V. A tiempo completoJob Title:Quality Assurance Manager Hsio CopperAbout the Role:We are seeking an experienced Quality Assurance Manager to join our team at Amphenol Tcs De México, S.A. De C.V.Key Responsibilities:Guarantee customer satisfaction by delivering products that meet or exceed quality standards.Empower quality inspectors through effective training and...
-
Quality Engineering Manager
hace 3 días
Mexicali, México Intuitive A tiempo completo**Company Description**: **Primary Function of Position**: The Quality Engineering Manager is responsible for managing the team of Quality Engineers and evaluating their results. Coordinates the support to production released assembly lines in Mexicali Operations. He or she interfaces with leaders including VPs and Directors throughout the design,...
-
Senior Quality Assurance Manager
hace 3 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoEstimated salary range: $60,000 - $90,000 per yearAbout the JobWe are seeking a highly experienced and skilled Senior Quality Assurance Manager to lead our quality assurance team at TPE de México, S. de R.L. de C.V.Key Responsibilities:Leadership and Team Management: Provide strategic direction and guidance to cross-functional teams to ensure compliance...
-
Quality Manager
hace 7 meses
Mexicali, México Emprego MX A tiempo completoDescripción y detalle de las actividades Communication and problem-solving skills while leading the Quality department toward company goals and objectives. Identify areas of continuous improvement within the quality department and in the Quality Management System. Provide development and training of the Quality team as well as other departments in all...
-
Quality Manager
hace 24 horas
Mexicali, México Vida Group International A tiempo completo**Responsibilities**: - Develops, implements, manages, and integrates a QMS for a manufacturing plant. - Develops a quality organization that is capable of implementing the company standard. - Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company’s product lines. - Leads...
-
Quality Manager
hace 5 días
Mexicali, México Emprego MX A tiempo completoDescripción y detalle de las actividades - Ensure that the Company’s quality system is implemented, and maintained in the Mexicali and SLRC facility. -Work with operations to develop, implement, and maintain effective statistical process controls and other statistical techniques to ensure manufacturing output is in control and constantly monitored....
-
Quality Manager
hace 6 días
Mexicali, México Emprego MX A tiempo completo**Descripción y detalle de las actividades** - This position is responsible for providing leadership and is assigned the authority to implement, coordinate and monitor the facility’s Quality System as it pertains to contract sterilization of medical devices. Acts as the facility’s Quality Representative, ISO Management Representative, and lead Quality...
-
Quality Assurance Project Manager
hace 3 semanas
Mexicali, Baja California, México Jonathan Mfg De México, S. De R.L. De C.V. A tiempo completoAt Jonathan Mfg De México, S. De R.L. De C.V., we are seeking a highly skilled Quality Assurance Project Manager to join our team.About the RoleWe offer an estimated salary of $90,000 per year, based on industry standards and market conditions in the region.The successful candidate will lead the development and implementation of quality assurance...
