Senior Quality Engineer

Medical Insurance

Flexible working hours

On-the-job training provided

Language courses

Professional growth opportunities

Company cafeteria

Free Gym in Offices

• Indefinite and stable contract in a project with a high global impact and in the midst of an international expansion process.
• Professional and personal development in a young and dynamic environment.
• Competitive salary based on experience and an attractive benefits package.
• Flexible schedule for personal/family work-life balance.
• Flexible compensation (restaurant vouchers, transport, and childcare).
• Access to the iWellness program: gym and physiotherapist in our facilities.
• Corporate events and gifts.
• Subsidized company canteen.

LVD Biotech - iVascular Group is an international medical technology group specializing in the development, manufacturing, marketing, and distribution of innovative medical devices for the treatment of vascular system pathologies worldwide. Our vertical integration model allows us to integrate the entire product lifecycle.

The group is formed by two highly specialized and complementary companies:

• LVD Biotech, our innovation center, leads and drives the research and development of new technologies, managing the complete product development cycle from the initial idea conception to the preparation of the registration dossier, including the generation and protection of knowledge through intellectual property.
• iVascular converts that innovation into medical solutions that reach healthcare professionals and patients through the manufacturing, logistics, marketing, and international commercialization of a portfolio of medical devices for the Coronary, Peripheral, and Neurovascular areas.

With a team of more than 600 professionals and a commercial presence in more than 86 countries, both companies work in an integrated manner in a continuous collaboration environment that combines science, innovation, industrial excellence, and the highest quality standards. Together, we drive the development of medical solutions based on cutting-edge technologies with a common goal: to improve the quality of life of patients worldwide.

We are currently looking for a Senior Quality Engineer to join the Quality Department.

To do this, you will evaluate, develop, and implement preventive quality measures, in-process controls, and the strengthening of processes and raw materials. As a fundamental part, you will also monitor and analyze incidents and production and field data to identify and resolve problems in the most agile and effective way.

Guarantee that manufactured products meet the quality requirements and specifications established by the company and by various regulations before being released to the market. Ensure that product issues during production are managed in an agile, comprehensive, and profound manner according to risk. Ensure the robustness of processes, products, and preventive measures to issue products free of deficiencies.

• Responsible for ensuring that non-conformity management is carried out according to established requirements.
• Identify the grouping and priority of problems to focus resources.
• Lead the investigation or collaborate in the investigation together with the Technical and Operations Areas. Ensure that the root cause is identified and that the recurrence of problems is avoided.
• Propose, collaborate, and agree upon the disposition of materials and semi-finished goods in an agile and effective manner. Perform monitoring and trends and propose CAPAs.
• Collaborate in the investigation of customer complaints.
• Ensure that process PFMEAs are carried out effectively.
• Participate in product risk analyses.
• Perform risk analysis of non-conformities.
• Participate in design reviews
• Ensure that product quality plans are implemented satisfactorily, including process and raw material parameters and quality attributes.
• Participate in product transfers and changes. Participate in process changes and in meeting their deadlines.
• Evaluation and monitoring of raw material non-conformities together with Quality Control
• Analyze supplier response
• Collaborate in supplier audits
• Review and approve equipment qualifications and process and software validations
• Propose new equipment and manufacturing or control tools
• Collaborate in the drafting of manufacturing instructions so that they adequately capture the necessary steps, controls, and verification elements.
• Collaborate to ensure that the Quality System has been effectively implemented in the production area, specifically: document control, training plans, non-conformities, change controls, GMPs, validations and transfers, traceability of materials and products, and data integrity.
• Collaborate in the definition of quality objectives and indicators, the performance of internal audits and process inspections, and assurance.
• Collaborate in the identification of quality management system requirements to comply with the regulatory requirements of the jurisdictions where product commercialization is planned.

Academic background: Bachelor's degree in engineering or other related disciplines.

Training in ISO 13485, MDR, MDSAP, and 21CFR.

Experience: From 8 years of experience in a similar position.

Skills and attitudes:

A person with analytical, proactive, decisive, rigorous, and organized capacity.

With ease in communication and social relations.