Capas Compliant Coordinator

Operating Company: Spark
Location: Mexicali,Baja California,MX
Date Posted: November 15, 2023
Req Number: R5018155
- Provides Support to the Operations and Quality Assurance area to ensure implementation and effectiveness of the Organization’s Corrective and Preventive Action system.
- Provides Support to the Quality Assurance manager and Quality Assurance Director with the collection and analysis of internal and external quality system data (Customer complaints, Material Rejection Reports, Field actions, etc) to determine the need to initiate corrective and preventive actions.
- Coordinates the investigation of rejections and external complaint trending as well the creation of action plans in response to internal and external product / quality system issues.
- Prepares and manages CAPA files throughout all the different phases in accordance with internal policies and procedures.
- Coordinates on time closure of Action planes thought daily management and tracking tools such as visual management boards or electronic spread sheets.
- Prepares and distributes Monthly CAPA reports and Coordinates the organizations CAPA meetings with CAPA review board team members.
- Provides Support to the Quality Assurance manager and Quality Assurance Director with communication and correspondence with Corporate team members in accordance with internal policies and procedures.
- Coordinates and follows up on the training and guidance to CAPA owners as required.

**Job Requirements**:

- Bachelor’s Degree: Industrial Engineer, Mechanical Engineer, Electronics Engineer, or similar.
- Team player, Customer focused
- English 85% Preferred (spoken, written, read)
- Experienced in QMS and ISO Standards (ISO13485 and/or FDA GMP)

LI-PB1

**Operating Company**:
Spark