Business Area:
- Employment type: Full-time**A global job position with an impact**:
We are growing and expanding our Manufacturing Site in Mexico! In the job as Quality Engineer, you will have the opportunity to actively support the organization by meeting ensuring that our manufacturing site runs as needed to have the growth expected of the products we make in Mexico, excel in your own daily tasks and responsibilities, and experience a very varied working day in a dynamic.
Objective:
The Quality Engineer is responsible to ensure that our processes and products are following our Quality System, to improve our Quality system and to improve the quality of our products and processes.
**Duties/Responsibilities**:
- Develop statistics for relevant areas.
- Present KPI's.
- Perform and responsible for complaint handling.
- Act as internal auditor.
- Evaluate and make decisions on the system for nonconforming product.
- Ensure that nonconforming products are reviewed and evaluated.
- Ensure that nonconforming products have a disposition.
- Responsible for nonconformities being documented, analyzed, resolved, and justified.
- Promptly create procedures for rework.
- Provide training on reworks.
- Maintain the corrective and preventive system.
- Evaluate KPI's, audits, processes, non-conformities, and other areas to determine if
CAPA's are needed.- Establish root cause analysis to ensure that the reasons for the CAPA's are being
addressed.- Identify actions to solve CAPA's.
- Verify that the CAPA's actions are effective.
- Document all CAPA's and actions.
- Responsible for complaint investigation, records, and statistics.
- Designated Release Officer for assigned area. Responsible for the conformity of Ambu
A/S and King System owned medical devices are appropriately checked in
- accordance with the QMS under which the medical devices are manufactured.- Lead Quality Inspectors supporting assigned area.
- Final release of Ambu A/S and King System products.
- Reject to release the product/lot and escalate any problems to NCR/CAPA
- Reject the release of product/lot, if disagreeing with the disposition of a NCR or CAPA
- Make NCR's, CAPA's and SCAR's following our existing procedures.
- Stop manufacturing if production represents a quality risk.
- Put product on hold
**Education and Experience**:
- Bachelor's degree in a related field
- 5+ years of experience working in Quality.
- Experience on medical device industry
- Experience working in manufacturing preferred
- Must be able to read, write and understand English.
**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.
**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 4,500 people in Europe, North America and the Asia Pacific.
