CAPA Engineer

Postion Purpose The primary function of this position is to plan, coordinate and execute the investigation activities from initiation until sign off/completion of the written exception report. This position is responsible to solve quality problems and/or investigations in order to identify the true root cause of problems and implement effective solutions at the manufacturing process. Get involved in the business units assigned and provide quality criteria contributions when applicable. Position Responsabilities Partners with investigation record owner to assure through investigation Helps drive investigation to root cause using systemic investigation approach and root cause analysis tools Assists with the impact assessment. Helps document investigation analyst findings and corrective actions as necessary. Collaborate in writing the investigation report to ensure is writing in the way that it compliance with all regulatory requirements. Plan, coordinate and execute the investigations activities from initiation until sign off/completionof the witing exception report. Collects and reports on Quality System metrics Participates and collect data related to Managment review process. Participate in Quality Culture engagement activities. This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). Engage others, promote and participate in 5s initiatives to contribute in the continuous improvement of our site. Education and Experience: Bachelor’s degree from an accredited college or university. Three to five years of experience in a FDA regulated company or similar environment with Quality System experience in GMP and ISO quality system standards. CQE, Six Sigma Green Belt, Microsoft Office, AS400, SAP, Trackwise, Nonconformance tracker system desirable. English fluency Technical Knowledge and Skills: Good leadership, collaboration and stakeholder managment skills Excellent verbal communications skills and technical writing ability Excellent skills to develop quality assurance plans, policies/procedures and systems to meet standards and business requirements Good decision making and problem solving skills. Abilities Ability to work in a cross-functional global environment Ability to coordinate and lead project team activities in an effective and proficient manner Planning and Decision Making The incumbent will have full responsibility for decisions within normal boundaries. Decisions will naturally be consistent with business objectives, but technical decisions are generally made independently. General guidance and direction will be provided by direct management, but the incumbent will operate independently most of the time. This position has authority to request operations to implement immediate containment actions if necessary due to a quality issue. ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Location: Nuevo León, MX

Posted Date: 4/26/2025