Job Description

At Hologic, a leader in women's health innovation, we empower people to live healthier lives every day. Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Engineer 2 toprovide engineering support for on-market medical devices. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.

This position will work Shift B, which is 2pm-10pm from Monday to Saturday. This is an onsite role in Alajuela CR.

of Duties and Responsibilities / Resumen de funciones y responsabilidades:

• Plan, coordinate, optimize, validate, and implement process improvement in conformance with quality requirements and guidelines established by the applicable regulations to improve product quality indexes.
• Provide technical support, engineering tools training and mentoring to Quality Engineers 1 and Quality Engineering Analysts.
• Provide adequate technical support regarding Quality Engineering or Quality Control issues through the proper interpretation of specifications, acceptance criteria and regulations in order to resolve issues with processes, raw materials or equipment due to assignable causes or system issues and therefore assisting in the identification of root causes and contribute ideas to resolve such issues.
• Lead containment meetings, assess impact risks and participate in the elaboration of action plans to mitigate or correct quality issues detected in manufacturing lines.
• Coordinate, lead, participate and aid interdisciplinary teams (CSPO) to positively impact the strategic objectives of the corporation to achieve operational excellence.
• Maintain ongoing communication with all CSPO members (local and/or extended) to facilitate the decision-making process that impacts product, manufacturing line and/or project performance.
• Assist and execute the investigation of product failures, customer complaints, rejects and failures detected in the quality system to establish adequate preventive and corrective actions.
• Facilitate and process Non-Conformance Event (NCE) to ensure proper segregation, identification, and disposition of materials.
• Review and update documentation under the responsibility QA and elaborate new documentation and procedures to ensure the continuous improvement of the quality system.
• Review and approve change orders and/or protocols, and reports to ensure the adequate implementation of production processes and systems.
• Develop, support and/or execute validations to ensure proper implementation in conformance with regulations, standards, and good practices to achieve operational excellence.
• Support investigations generated by customer complaints, whenever necessary, to identify the root cause and contribute ideas to correct the failure mode.
• Execute and implement assigned actions -in a timely manner- as required by the Quality System (CAPA, IACA, PA, COR, among other) to correct any issues related to system failures.
• Lead and/or perform continuous improvement tasks for processes, inspections and measurements, internalization projects or the introduction of new products to increase productivity and meet the goals of the organization in search of operational excellence.
• Provide information to Management for the planning of yearly targets and processes.
• Implement, promote and/or support the use of quality and statistical tools for the various activities performed and/or supported by the Quality Engineering Area.

Education/ Educación: University Degree: B.Sc. Engineering or similar.

Experience / Experiencia: 2-year experience minimum as a technical field professional and in similar positions.

Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): Statistics, Problem Solving, Process Improvement, Risk Management, CFDR 820

Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish and 90% English Fluency C

Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: Minitab, Visio, Gantt Char

Qualifications / Cualificaciones:

• Leadership
• Decision-making and problem solving.
• Planning and Organization
• Teamwork
• Oral communication skills
• Task committed

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