Quality Assurance Specialist

Stryker Group; Ciudad de México; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading medical device company in Mexico is seeking a Quality Management Auditor. Responsibilities include managing internal and external audits, preparing documentation, and training personnel. Candidates should have a Bachelor’s degree in a related field and at least 2 years of experience in quality management, preferably in the Life Sciences sector. Intermediate English proficiency is required.

Formación

• Minimum of 2 years of experience with quality management.
• At least intermediate proficiency in English.
• Previous experience in the Life Science sector (Medical Devices, Pharmaceutical).

Responsabilidades

• Responsible for Internal Audit Management to ensure compliance with quality standards.
• Prepare documentation for external audits conforming to regulatory requirements.
• Audit suppliers to ensure they meet quality requirements.
• Manage documented information related to the quality management system.
• Control internal and external documented information for accuracy.
• Execute training programs related to the quality management system.
• Handle complaints and customer feedback for quality improvement.
• Determine root causes of non-conformities and follow up on action plans.

Educación

Bachelor’s degree in quality areas

Descripción del empleo

What you will do

• Responsible for Internal Audit Management that involves planning, execution, and closure of internal audits to ensure compliance with the organization's quality management system standards. It also encompasses the monitoring of the effectiveness of corrective and preventive actions (CAPAs) to address identified non-conformities.
• Responsible for External Audit Documentation Preparation that involves the preparation of necessary documentation for external audits. The documentation must conform to applicable regulatory requirements and medical industry standards.
• Responsible for Auditing Suppliers and Indirect Channels. Auditing suppliers and indirect channels to ensure that they meet the organization's quality requirements. The audits may encompass the assessment of the suppliers' quality management systems, manufacturing processes, and product or service quality.
• Responsible for Documentation Management for Quality Management System that involves preparing, reviewing, and registering documented information related to the quality management system. The documented information includes quality manuals, procedures, work instructions, and records.
• Control of Internal and External Documented Information that involves controlling the internal and external documented information to ensure its accuracy, completeness, and integrity. The control may include document approval, distribution, revision, and obsolescence.
• Quality Management System Training Execution that involves preparing and executing training programs related to the quality management system. The training may cover quality policies, procedures, work instructions, and other relevant topics.
• Handling Complaints, Feedback, and Surveys. Responsible for receiving, generating, and following up on product or service complaints. It also includes attending to customer feedback and analyzing customer satisfaction surveys. The objective is to identify opportunities for improvement and to address any areas of dissatisfaction.
• Responsible for determining the root cause of non-conformities and CAPAs and following up and closing action plans to prevent recurrence and improve the quality management system.

What you need

Required:

• Bachelor’s degree in quality areas (Industrial Engineer, Chemical engineer, Pharmaceutics, QFB, Industrial Chemistry, etc.).
• Minimum of 2 years of experience with quality management.
• At least intermediate proficiency in English.
• Previous experience in the Life Science sector (Medical Devices, Pharmaceutical).

Desired:

• Experience attending an internal auditor course for ISO 13485 or ISO 9001:2015.
• Quality Management specialization and leader auditor certification in ISO 9001:2015 or ISO 13485:2016.