CAPA Engineer - Monterrey, N.L. - ICU Medical

Descripción

Position 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 for solving 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 Responsibilities

• Partners with investigation record owner to assure thorough investigation.
• Helps drive investigation to root cause using systemic investigation approach and root cause analysis tools.
• Assists with impact assessment.
• Helps document investigation analyst findings and corrective actions as necessary.
• Collaborates in writing the investigation report to ensure compliance with all regulatory requirements.
• Plans, coordinates and executes the investigations activities from initiation until sign off/completion of the written exception report.
• Collects and reports on Quality System metrics.
• Participates and collects data related to Management review process.
• Participates 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).

Engages others, promotes and participates in 5S initiatives to contribute to 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 management 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.

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.