Business Area:
- Employment type: Full-time**global job position with an impact**:
We are growing and expanding our Manufacturing Site in Mexico! In the job as Quality System 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 System Engineer is responsible to performs quality systems duties, including maintenance of Corrective action and Preventive action (CAPA), Nonconformance process, planned deviation process among others, this position will also ensure and maintains a state of inspection readiness.
**Duties/Responsibilities**:
- Ensures compliance of the Corrective Action and Preventative Action, NCR, and Planned Deviation processes.
- Serves as site trainer for the Corrective Action and Preventative Action (CAPA), Nonconformances systems and Planned Deviation process.
- Provide coaching and guide teams to follow QMS processes.
- Leads quality projects with cross functional teams.
- Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
- Makes proposals and assists in the development of corrective and preventative action plans and monitors implementation.
- Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness.
- Facilitate the tracking and closure of corporate Nonconformances (NCs) to ensure consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality, and thoroughness of content.
- Facilitate quality metrics gathering, analyzing, and reporting on a regular basis. Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization of key quality system processes (i.e., Management Review, Corrective and Preventative Actions, monitoring meetings, etc.
- Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes.
- Assesses current quality systems and recommends improvements to enhance quality and reduce cycle time.
- Monitors trends, identifies issues, recommends, and implements appropriate actions.
- Assists in the development, implementation, and review of standard operating procedures.
- Maintain current knowledge of the regulations and ISO 13485 applicable clauses.
- Has thorough understanding of process criteria and regulations and business impact of decisions and actions.
- Conduct internal audits as needed and support external audit. Includes any other additional duties identified by management
**Education and Experience**:
- Bachelor's degree in a related field
- 5+ years of experience working in Quality Assurance/Systems.
- Experience on conducting Root Cause Investigations.
- PLM system/change management knowledge.
- 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.