Quality Engineer

hace 1 mes

Alajuela, Alajuela, Costa Rica Cardinal Health A tiempo completo

Key Responsibilities

Assist in ensuring compliance with electronic documentation systems as eDHR and Infinity QS with internal procedures and regulations such as ISO13485 and FDA.

Collaborate with multifunctional teams to guarantee that the updates the electronic software configuration are implemented according to manufacturing and engineering needs.

Perform validations of the electronic documentation systems due to updates as required.

Participate in corporate validations of the Quality Software's as applicable.

Offer daily support to the manufacturing floor for issues related to electronic documentation, related to QA software.

Perform and/or collaborate in CAPAs and NCRs that may be related to an electronic documentation system.

Propose and implement opportunities of improvement to create user-friendly electronic documentation systems.

Develop and update procedures related to the use and maintenance of the Quality Software's.

Perform training as required to ensure correct use and maintenance of the Quality Software's.

Participate in internal and external audits as QA Software Maintenance SME.

Ensure compliance with training requirements.

Perform data analysis for KPIs and other quality objectives/projects as required.

Participate and collaborate in the Internal Audit Process.

Perform other related duties as required.

Responsibilities and Roles EHS

Responsibilities

  • 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.

Requirements

University studies initiated in Industrial, Chemical, Mechanical Eng. or similar and/or equivalent experience.

Preferred: Three years in medical device and/or pharmaceutical manufacturing environment.

Must 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.

Dealing 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.

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