Quality Systems Specialist

**City**:Juarez

**State**:
**Country**:Mexico

**Business Area**:Quality Assurance

**Department**:QA/RA, Juárez

**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 Systems Specialist, 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 Systems Specialist is responsible to performs quality systems duties including maintenance of Nonconformance process, planned deviation process among others. And for ensuring that the document control is done in accordance with the requirements.

**Responsibilities and Essential Functions**:

- Ensures all quality documents fulfill the applicable requirements.
- Maintains quality records on product testing, nonconformance in an accurate and

timely manner.
- Ensures documents are approved and distributed as intended.
- Ensures that document changes are controlled, approved and distributed.
- Ensures that all distributed documents are identified and in the latest version.
- Ensures compliance of the Change Control process.
- Provide Agile Training in Change Control for MX site.
- Provide support for the compliance of the NCR, and Planned Deviation processes.
- Serves as site trainer for the NCR and Planned Deviation processes.
- Participate in quality projects with cross functional teams.
- Facilitate the tracking and closure of local 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.
- Report on the performance of the Nonconformance process for review and as a basis

for improvement.
- Conducts investigations, collects data, analyzes trends and prepares reports for a

assigned quality processes
- Assists in the development, implementation, and review of standard operating

procedures.
- Provide support in external audits as needed.
- Includes any other additional duties identified by management required to help and

support the quality processes. Compilers with Ambu practices.
- ** Authority**:

- Reject document submissions that are not in compliance with applicable Document

Control procedures
- Create NCR's and Deviations following existing procedures.
- Escalate any situation that represents a quality risk.

**Qualifications / Education**:

- Technical degree in a related field (bachelor's degree preferably).
- 2 years of experience or more working in the medical device industry
- PLM system/change management knowledge.
- Knowledge on Root Cause Investigations tools.
- Knowledge on non-conformance processes.
- Must be able to speak, 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.