Quality Assurance Validation Specialist
2 weeks ago
Position Title: Validation Engineer
Key Responsibilities:
- Support engineering, manufacturing, logistics, and quality teams in validation activities for equipment.
- Document findings and communicate solutions effectively to both internal and external stakeholders.
- Create necessary validation documentation as required.
- Execute validation tasks associated with designated projects.
- Facilitate process enhancements and implement controls for specific projects.
- Work collaboratively with program managers to schedule and carry out validations for assigned initiatives.
Required Qualifications:
- Bachelor's degree in Engineering or a related technical discipline.
- A minimum of 5 years of experience in engineering or quality assurance roles.
- Familiarity with standards and submissions in the medical industry.
- Assist the validation team with all essential quality and validation tasks for assigned equipment.
- Contribute to the development and execution of comprehensive validation plans.
- Prepare and implement the Design of Experiments (DOE) Matrix and execute processes accordingly.
- Analyze data and optimize key parameters based on inspection outcomes.
- Conduct process optimization trials.
- Prepare and review reports on process development and engineering studies.
- Develop, approve, execute, and monitor Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) protocols.
- Review documentation as needed and coordinate corrective actions to address issues.
Additional Qualifications:
- Excellent verbal and written communication skills.
- Knowledge of FDA 21 CFR, 21 CFR Part 11, and ISO 13485 regulations.
- Ability to collaborate effectively within teams.
- Six Sigma Green Belt certification is preferred.
- Experience in Quality Management System (QMS) implementation.
- Background in manufacturing medical industry components.
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