Quality Systems Engineer Iv

hace 6 horas

Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**_MAIN PURPOSE OF ROLE_**

**_ MAIN RESPONSIBILITIES_**
- Provides Quality System Body of Knowledge support to the organization.
- Lead cross functional teams to execute Quality System initiatives.
- As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
- Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations.
- Support and execute internal/external Quality System audits
- Ensures compliance to all Quality System Regulations and policies applicable to SH Structural Heart/ CAHF Cardiac Arrhythmias & Heart Failure units in Costa Rica by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements
- Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to SH Structural Heart/ CAHF Cardiac Arrhythmias & Heart Failure units in Costa Rica
- Supports, executes and resolves investigations related either to non-conformances or improvement opportunities.
- Works with the organization during new product introductions to ensure quality deliverables such as Quality Plans and Risk Management are in place for the products being transferred
- Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions
- Supports the CAPA System elements for the site
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Might be responsible for specific areas within the quality systems organization, driving for excellent operative execution and personnel management (facilitation, training and development)
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
**_ QUALIFICATIONS_**
- Bachelor's Degree.
Engineering, Business Administration, Human Resources or Science
- At least 5 years of total experience, with 2+ years in Quality Systems, Compliance positions, or demonstrated equivalent experience in Quality (demonstrated knowledge of Quality Engineering, Training, Documentation, Microbiology, Testing and/or Quality Release).
- +2 years of experience in an FDA (QSR), ISO 13485 or ISO 9001 controlled industry
- Knowledge and Application of process improvement such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.
), Six Sigma or Process Control & Monitoring (SPC).
- Demonstrated knowledge of quality systems including but not limited to Training, Documentation, Microbiology, Testing and/or Quality Release

**_ Language Proficiency_**
- Advance Commands of English / Required

**_ Preferred Qualifications & Education_**
- Quality Auditor training for ISO 13485 or 9001
- Certified Quality Engineer.
- Quality Systems related certifications (Quality Control, CAPA, Risk Management, etc).
- Masters (in progress or completed) on Quality Management, Operational Excellence, Project Management or similar.
- 1-2 years of experience participating on ISO and/or FDA audits is a plus

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