Quality Engineer managing quality engineering processes in an innovative medical device company. Leading strategic projects and ensuring compliance with regulatory standards.
Responsibilities
Organize continuous improvements and opportunities for change in QE processes.
Manages strategic QE projects.
Ensure compliance with appropriate regulatory, quality requirements and company policies.
Manages and resolves complex quality relation issues.
Supports Operations ensuring appropriate process controls are in place to prevent product performance quality issues.
Supports SAP implementation and sustaining activities.
Support the Quality Engineering area Developing, writing, execution and reporting of validation efforts such as Computer System Validation.
Executes protocols for validation, qualifications, and computer software.
Investigates and researches equipment, process, computer software to develop protocols to confirm by examination and provision of objective evidence that they consistently produce a result or product meeting its predetermined specifications.
Supports management in developing the validation strategy, implements and monitors it, and reports status to management.
Requirements
Bachelor Degree in industrial engineering, chemical engineering, industrial chemical engineering, biomedical engineering, electromedicine or related filed.
Advanced English (speaking and reading)
2 years of experience in medical industry.
Need to get B2 scored.
Assessment Center Competency-based interview with hiring manager.
Benefits
Equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.
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