Quality Engineer

hace 2 semanas

Ciudad Juarez, México Ambu Denmark A tiempo completo

Business Area:
- Location: Ciudad Juárez, MX- Country:
- Employment type:
As part of the newest Operation Plant and Staff member team, you will support a completely new operation in Juarez, product transfers and in supporting developing and supporting the introducing corporate quality system of our medical devices within our product range.

**A global job with an impact**
In the job as Quality Engineer, you will have the chance to impact product development and your own daily tasks and responsibilities. You will experience a very varied working day in a dynamic organization. You will work closely with your colleagues, particularly colleagues in Juarez, Denmark and Asia and in the US.

**Responsibilities**
- The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Conduct benchmarking with sister sites to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO) including providing support during internal and external audits
- As applicable, provides supervision, mentoring, coaching, performance review, and developmental plans for others
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Designs or specifies quality plans, performs risk assessment and testing mechanisms of material, equipment; conducts quality assurance tests; and performs statistical analysis to assess the risk and determine the responsibility for products or materials that do not meet required standards and specifications.
- Leads process validations (PVP/IQ/OQ/PQ/PVR), software validations, cleanroom validations and component qualifications.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
- Complies with EHS practices.

**Work Environment**:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.

**To succeed in the job, you will need to have as a must the following**:

- Bachelor’s Engineering Degree preferably or related technical field
- More than 5 years related experience
- Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
- Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
- Ability to organize and follow up on multiple priorities.
- Ability to make decisions which will effectively support the business and company policies.

**How to Apply**

**About Ambu**:
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 5,000 people in Europe, North America and the Asia Pacific.

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