Sr. Quality Manager

**EMPRESA IMPORTANTE**

**Solicita**:
**Sr. Quality Manager**

**Descripción y Requisitos**

**Position Summary**
The Quality Manager will ensure the overall quality of a finished-good product that is designed and/or manufactured internally or through the approved supply chain. This position ensures that projects and products are capable and will meet specified standards and customer requirements. As a Sr. Quality Manager, you will be involved in a both short design change efforts and longer-term new product development projects. Regular use of problem-solving tools and statistical analysis to support design verification & validation, definition of acceptance criteria, risk assessments, and investigation. As a leader within the Quality department, this position will participate in strategic initiatives including integration of acquisitions, manufacturing transfers, and continuous improvement activities. The position will lead a cross functional team and is expected to drive a strong focus on team development, engagement, and professional growth.

**Position Qualification** Knowledge**:Acquired through education, certifications, training, experience.
- Knowledge of quality standards for medical devices (e.g., ISO 13485, FDA QSR, MDSAP, EU MDR, and Canadian Medical Device Regulations.

**Skills and Abilities**:

- Fluent in English and Spanish
- Excellent verbal and written communication skills.
- Excellent organization skills and attention to detail.
- Ability to multi-task.
- Sound, systematic problem-solving skills.
- Strong computer skills: MS Word, MS Excel, PowerPoint, Database Management and Statistical Analysis.

**Level of Experience**:

- A minimum of 5 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).
- A minimum of 5 years in a leadership role, leading and mentoring employees

**Level of Education**:

- Bachelors degree in Business, Science or Engineering

**Travel**:

- Occasional overnight travel (up to 25%).

**Essential Duties**
***
**and Responsibilities**
- Lead, develop, and mentor a multi-site team within the quality organization.
- Drives for collaboration across all departments and operates with a service driven leadership style.
- Leads by example, promoting a culture that values our people with open communication channels.
- Represents customer requirements internally, ensuring our #1 guiding principle for Customer First.
- Ensures customer receives excellent service with quality concerns through timely responses and products.
- Communicates with outside departments within the plant and in other company facilities to ensure a continuous operational flow.
- Investigates operational and technical issues, leading root cause and troubleshooting activities, resolution of problems, and thoroughly documented activities.
- Leads site-level audits for external agencies and customers and facilitates closure of audit findings.
- Maintain SOP's and quality control documents for product and manufacturing.
- Utilizes data to drive quality control results.
- Serves as a leader on the Global RAQA team, working collaboratively on setting Global direction and driving consistent and standardized processes across all sites.
- Reports to upper management on the performance of product quality and any need for improvement
- Responsibility to own, review and approve documentation: change control, validation protocols and reports, test reports, nonconforming dispositions, CAPAs and customer complaints.
- Create, identify, and report on quality metrics weekly and monthly.
- Ensures all Quality System documentation is accurate and comprehensive.
- Identify areas of opportunity and support continual improvement of the Quality Management System.

Puesto: Calidad - Gerente**Información Adicional**
- Tipo de contrato: Permanente- Salario: Negociable
- Pais: MEXICO
- Estado o Region: Chihuahua
- Ciudad: Ciudad Juarez