Quality Assurance Engineer  WMT-MX.

Full-time, on-site position in Arteaga (Saltillo, Coah. Mx), for Weidmann Medical Technology

Join our team to further inspire a culture of innovation.

Allow us to introduce ourselves…

We are a globally active family company whose sustainable and responsible actions contribute to improved living standards. We are an attractive employer with a value-oriented corporate culture based on trust, appreciation and continuous improvement.

Weidmann Electrical Technology has been at the heart of the global transformer industry for over 140 years. With deep rooted knowledge in the design, development and operation of transformers, Weidmann is a leading integrated solutions provider for specialized product and services in the energy sector.

The role…

Support and provide assistance for the effective implementation of the Quality Management System, ensuring compliance with required Mexican and international regulations.

Develop and monitor control methods for the manufacturing processes of medical devices, including plastic injection products in Medical Technology, in accordance with customer requirements.

How you’ll make an impact…

• Periodically report the results of the Quality Management System.
• Ensure that procedures and documents related to the Medical Technology Quality System are implemented and monitored during execution.
• Inform TM Quality Management about the effectiveness of the ISO 13485 Quality System and improvement needs.
• Ensure that established procedures are implemented to promote awareness of applicable regulatory requirements and the regulation-based Quality Management System.
• Maintain the Medical Technology documentation system updated and communicated to involved personnel.
• Investigate customer nonconformities and ensure appropriate actions are taken to prevent recurrence.
• Perform specialized quality-related studies when required.
• Support and execute external and internal audits for the Medical Technology area.
• Identify and report quality-related nonconformities of critical suppliers.
• Review internal and external rejection indicators with the production area to jointly define corrective or preventive actions.
• Ensure that Good Manufacturing Practices and Good Documentation Practices in Medical Technology are communicated and applied by involved personnel.
• Ensure that cleanroom access and operation procedures are communicated and implemented for involved personnel.
• Ensure qualification of suppliers of goods and services that impact product quality to comply with negotiated Quality Assurance Agreements.
• Conduct follow-up audits of qualified suppliers to ensure compliance with negotiated Quality Assurance Agreements.
• Manage Quality Assurance Agreements signed with suppliers with qualification potential to ensure correct negotiation of quality requirements.
• Collaborate in the development of current and potential suppliers to ensure compliance with TM quality requirements and negotiated Quality Assurance Agreements.

What do you bring…

• Knowledge of medical device and/or pharmaceutical manufacturing processes.
• Minimum of three years of experience in a similar position within the pharmaceutical or medical device industry, including management of quality systems such as: Complaints, Nonconformities, Root Cause Investigation, CAPAs, Change Controls, Supplier Management, Internal Audits, In-Process Control, Validation Processes, Regulatory Compliance, and Documentation.
• Knowledge of applicable regulatory requirements for medical device manufacturing.
• Knowledge of Good Manufacturing Practices and Good Documentation Practices. Knowledge of Mexican Official Standard NOM-241 (medical devices) and desirable knowledge of NOM-059.
• Knowledge of ISO 13485, ISO 14001, and ISO 45001 systems.
• Knowledge of Automated Manufacturing Good Practices (ISPE-GAMP5).
• Preferably, knowledge of validation and commissioning processes based on ISPE guidelines.
• Advanced level of oral and written English proficiency.
• Knowledge of Statistical Process Control.
• Knowledge of ISO 14644 standards for Cleanroom Management (ISO Class 7).

What do we offer?

• Competitive salary and Compensation package
• Health and life insurance.
• Diversity and inclusion programs
• Management position in a global company
• Career plan
• Atractive Variable Bonus System

We look forward to hearing from you soon!

TO APPLY: Please send your resume to the following email: fatima.samaniego@weidmann-group.com

At Weidmann we are committed to equal opportunities and growth for all talents. We are convinced that a diverse and inclusive work environment increases mutual understanding and innovation of our business.