Process Quality Engineer

Your Role

• Analyzes defects for determining dispositions/drives management of Non-Conformances (NC) and Quality Notifications (QN) and implements effective Corrective and Preventive Actions (CAPA) actions.
• Assists in the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Supports operations performance monitoring, risk assessment, reporting, improvement and development, aids with improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and purchasing.
• Coordinates timely quality engineering and quality assurance tasks, aids in ensuring manufacturing quality systems are maintained, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
• Identifies transformative process enhancement opportunities, facilitating the execution of advanced improvement initiatives to optimize operational performance and elevate product quality benchmarks significantly.
• Applies advanced statistical analysis techniques proficiently to interpret complex data trends and resolve medium to high complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
• Ensures the comprehensive execution of process validation protocols, coordinates multifaceted production activities to bolster process validation efforts and drive continuous process improvements effectively.
• Prepares and delivers detailed quality metrics and reports to key stakeholders, highlighting significant achievements, emerging trends, and targeted areas for advanced improvement initiatives and regulatory compliance strategies.
• Participates in investigations and collaborates with suppliers, Research and Development (R&D), and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.

You're the right fit if

• You have a minimum of 1+ years’ experience working in highly regulated product/manufacturing environments (FDA-Medical Device preferred) with a focus on Quality/Process Engineering, Continuous Improvement, Design Transfers, CAPA’s etc.
• You’ve acquired previous internship or co-op experience in quality engineering within ISO regulated environments.
• You’re able to exercise good judgment in working within defined procedures/policies to determine appropriate action in working with supervisors and functional peer groups to gain cooperation of others.
• You have proven experience participating in investigations and collaborating with suppliers, R&D, and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.
• You have experience in Risk Assessment (ISO 14971), Process Failure Mode and Effects Analysis (PFMEA) and Root Cause Analysis.
• You have experience applying statistical/data analysis techniques to interpret complex data trends, performance monitoring, reporting and resolving medium to high complexity requests.
• You have a minimum of a Bachelor’s Degree in Engineering-Required.
• ASQ certifications are desired.