Iago Rodriguez Seijo

As Quality Engineering Lead, my main responsibility is supervising the day-to-day work of the quality engineers as well as the following tasks:

• Managing the non-conformity process, including the investigation and root cause analysis (8D, Ishikawa, 5Why) of the NCs and actively inputting into the disposition of non-conforming product.
• Leading the validation process and performing validation activities to ensure that it is in compliance with regulatory and international standards such as MDR, FDA and ISO 13485.
• Supervising and monitoring the calibration and maintenance process.
• Supporting the internal program by conducting internal audits ensuring compliance of the internal process with ISO 13485, MDSAP and MDR requirements.
• Managing the supplier evaluation and monitoring process including the supplier audit program. In addition, conducting on-site supplier audits to ensure requirements defined in purchase order are met.
• Supporting the validation and revalidation of the cleanroom ISO Class 7.
• Taking part in the change control process by raising ECs or by evaluating the risk of the changes.
• Conducting risk assessments related to suppliers or manufacturing processes.
• Analysing data and feeding information to management review meetings.
• Managing a team of two Quality Engineers.

Managed an ISO 13845:2016 certified Quality Management System for a BD facility as a Quality Engineer. Main responsibilities include:

• Managed QMS change control and updating process to meet customer and ISO 13485 requirements ensuring a risk-based approach.
• Led CAPA process as CAPA Site Lead, conducted root cause investigations using 8D, 5Why, and Ishikawa methodology.
• Oversaw customer complaint process, facilitated investigations, and provided support to cross-functional teams.
• Hosted internal and external (NB) audits.
• Implemented and managed the Material Review Board (MRB) process.
• Generated Quality Plans for QMS-impacting projects.
• Led and executed the Supplier Control process, including supplier assessments.

As a Quality Assurance Engineer my main duties are:

• Hosted internal and external audits (BSI, NADCAP, customer audits...)
• Developed and executed QMS changes to enhance processes in compliance with customer and AS9100 standard.
• Managed the Non-Conformance Review process (internal and external) including: led cross-functional teams through the root cause investigation (5Why, 8D, Ishikawa...), developing and executing corrective and preventive actions (CAPA).
• Conducted data analysis using Pareto and Heat Maps to identify opportunities for process optimization within the manufacturing stage.
• Managed a small team of 3 people.

Some of the main projects developed are:

• Supported and implemented the new Quality Management System Software and the new MRB process.
• Reduced the number of customer complaints in 70%.

As a quality engineer in an aluminium anodising plant with an inorganic coloration process, my main duties were:

• Oversaw quality control processes for setup of new anodising plant.
• Optimised manufacturing parameters to improve anodising results, enhancing overall product quality.
• Oversaw operation of waste-water treatment plant associated with anodising plant.
• Developed and implemented comprehensive quality control plans to enhance operational efficiency.
• Managed a small team of 7 people.
• Led troubleshooting efforts to ensure minimal disruption in operations.

Some of the main projects developed were:

• Commissioning of a new anodising plant with chemical brightening pre-treatment.