The Quality Systems Engineer is responsible for supporting and leading Quality System activities for new product development and commercial finished goods, including validations, resolution of non-conformances (root cause and corrective actions), CAPA, Quality System, and process improvement activities. This position ensures that systems, processes, and products meet regulatory, quality, and performance standards through rigorous testing and documentation.
Responsibilities
- Ensure Quality System Maintenance by developing and deploying quality procedures and documentation (including quality policies, standard operating procedures (SOPs), test methods, etc.), statistical sampling plans, and process capability studies.
- Support process improvements by utilizing lean methods, Kaizen, and Process Failure Mode and Effects Analysis (PFMEAs) to reduce product defects
- Support the calibration and maintenance scheduled for testing instrumentation to ensure all remains in a qualified state
- Develop and author validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for manufacturing equipment and processes
- Analyze statistical data from validation testing to identify deviations, determine root cause of failures and implement corrective actions
- Prepare comprehensive final validation reports summarizing test results and provide a clear conclusion on the qualification status
- Collaborate with cross-functional teams to ensure that validation activities are aligned with production schedules and project timelines
- Stay current with industry trends and regulatory requirements related to validation and quality assurance
Required Skills
- Five plus years of experience in a manufacturing environment performing validation activities
- Hands-on experience with equipment validation, software testing, or process control
- Familiarity with regulatory standards for OTC, Cosmetics, and or Medical Devices
- Bachelor's degree in Engineering or a scientific field
- Analytical and problem-solving skills to interpret test data and identify issues
- Attention to detail for accurate documentation and compliance
- Communication and teamwork skills to collaborate with cross-functional teams
