Overview


Título del trabajo: Ingeniero Jr de Calidad

Compañía: Cardinal Health

Descripción de funciones: SUMMARY OF POSITIONParticipates in the Quality System functions by providing maintenance to the configuration of thesoftware used by Quality and Operations to electronically document inspections and daily tasks.Example: Infinity QS and eDHR.Updates the configuration of the software’s used by quality and operations when engineering/manufacturing process changes occurred (validate as required) and provides dailysupport to the manufacturing floor when issues are raised. Ensures that the change control process for these processes is followed and up to date regarding internal procedures and external regulations.Creates training material as required to ensure population (operators, technicians, and engineers) using the Quality Software are properly trained to use the system. Executes continues improvement on the existing electronically configurations to reduce good documentation practices errors, reduce documentation time, with the finality of generating a user-friendly environment.Serves as a main communicator with IT corporate regarding global updates that may impact thevalidation state of the validated software.ESSENTIAL FUNCTIONS

  • Ensure compliance of electronic documentation systems as eDHR and Infinity QS with internal procedures and regulations as ISO13485, FDA and others.
  • Collaborates with multifunctional teams to ensure that the updates the electronic Software configuration are performed according to manufacturing and engineering needs.
  • Performs validations of the electronic documentations systems due to updates (as required).
  • Participates in corporate validations of the Quality Software’s (as applicable).
  • Daily support to manufacturing floor for issues related to electronic documentation , related to QA software.
  • Performs and/or collaborates in CAPAs and NCRs that may be related to an electronic documentation system.
  • Proposes and implements opportunities of improvement to create user-friendly electronic documentation systems.
  • Develops and updates procedures related to the use and maintenance of the Quality Software’s.
  • Performs training as required to ensure correct use and maintenance of the Quality Software’s.
  • Participates in internal and external audits as QA Software Maintenance SME.
  • Ensures compliance with training requirements.
  • Perform data analysis for KPIs and other- quality objectives/projects as required.
  • Participates and collaborates in the Internal Audit Process.
  • Performs other related duties as required.

RESPONSABILITIES AND ROLES EHSResponsibilities

ACCOUNTANT II
  • Comply with statutory responsibility under the national or federal regulations such as taking reasonable care of his or her own safety, health and welfare and of any other persons who may be affected by his or her acts or omissions at work.
  • Follow established EHS procedures and policies.
  • Encourage coworkers to follow EHS procedures.
  • Participate in employee engagement activities such as EHS inspections and EHS meetings
  • Report EHS incidents and hazards, assist in root cause analysis as appropriate, and cooperate in finding solutions or implementing improvement.
  • Complete required EHS training.

Roles

  • Require the use of Personal Protective Equipment.
  • Stop work in the event of contractors or other employees performing work that may lead to a serious injury or environmental incident.
  • Refuse to carry out an activity that jeopardizes the health of your own or staff and the building or facilities.
  • Refuse to perform operations/activities in which you are not trained or feel that your integrity is at risk.

REQUIREMENTSUniversity studies initiated in Industrial, Chemical, Mechanical Eng. or similar and/or equivalent experience.Preferred: Three years in medical device and/or pharmaceutical manufacturing environment.Preferred QualificationsMust be able to speak, read and write in the English language. Bilingual preferred.Requires excellent computer skills, proficiency in MS Office.Preferred: FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience.Preferred CompetenciesDealing with Ambiguity, Creativity, Customer Focus, Timely Decision Making, Decision Quality, Functional/Technical Skills, Innovation Management, Intellectual Horsepower, Learning on the Fly, Listening, Organizing, Perseverance, Planning, Priority Setting, Problem Solving, Process Management, Drive for Results, Managing Through Systems, Technical Learning.Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.To read and review this privacy notice click

Ubicación: Alajuela

Fecha del trabajo: Sat, 17 Aug 2024 23:13:59 GMT



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