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- Development and updating of the Quality Manual.
- Leads quality system audits for both clients and third parties.
- Ensures that procedures and policies are documented and controlled in the document control system.
- Adherence to quality system procedures.
- Develop the internal audit program, select, and train the internal auditor team.
- Provides support for the Customer Returns process.
- Participate in containment actions, corrective and preventive actions derived from the detection of non-conformities on the production floor.
- Provide support on the production floor based on detailed product knowledge.
- Use of statistical tools for failure analysis
- Feedback to the different departments involved to eliminate the root cause of the process.
- Ensure that staff procedures are implemented and documented in Document Control.
- Knowledge and application of knowledge IPC A
- Apply and maintain s + (constant cleanliness in the work area, classification of equipment, order of the models to be worked on)
- Comply with security policies, regulations, and procedures applicable to the company.
- Is the only one authorized to modify the Quality Manual.
- Has the authority for the planning and execution of internal audits (schedule, execution, report, etc.)
- Industrial Engineering or Bachelor of Administration.
- ISO Lead Auditor
- year experience in the medical industry (ISO )
- years' experience in a similar position.
- Knowledge of computer packages
- Knowledge of IPC A Acceptance Criteria
- Interpretation of visual aids
- Spoken and written English
- Ability to analyze and solve problems.
- Focused on results.
- Decision making
- Organized
- Analysis capacity
- Sense of urgency
- ISO Lead Auditor
- IPC A course certification
- Basic knowledge of using the HIOS interface.
- Availability to travel, Laser Visa, and valid passport.
Quality Engineer - Chihuahua, México - Copeland
Descripción
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