Nolato/GW Plastics
Position: Quality Engineer
Our client is consistently recognized as a “Best Place to Work” with a team-centric, collaborative and engaging culture. Located in rural settings near great health, cultural, educational and outdoor activities.
Overview
Serve as a high-velocity technical lead within the Vermont Operations quality engineering pool. This role is responsible for the full lifecycle of quality engineering across two facilities, ensuring 100% adherence to ISO 13485 and FDA 21 CFR 820 requirements. This position is a resource, capable of deployment in any facility to lead validations, investigations, and process controls.
Responsibilities
· Advanced Investigations (NC/CAPA): Lead complex nonconformance investigations using standardized Root Cause Analysis (RCA) tools (5-Why, Fishbone) to identify systemic breakdowns and ensure effective corrective actions.
· Process & Product Validations: Develop, execute, and write protocols and reports for IQ/OQ/PQ validations, including injection molding, secondary operations, and auxiliary manufacturing processes.
· Statistical Intervention (SPC): Beyond just "monitoring" data, the QE is responsible for establishing Statistical Process Control (SPC) alert thresholds and leading the technical intervention before a process goes into nonconformance.
· Software Validation (CSV): Coordinate and oversee Software Validation (CSV) for eQMS, MQ1, and production-related software to ensure data integrity and regulatory compliance.
· Supplier Development & Control: Manage the Approved Supplier List (ASL), execute critical supplier audits, and lead the Supplier Corrective Action Request (SCAR) process.
· Statistical Control: Implement and maintain Statistical Process Control (SPC), Gage R&R (MSA) studies, and process capability studies to ensure measurement system reliability.
· Design for Manufacturability (DFM) Support: The QE must participate in product design reviews to provide the "Quality Voice," ensuring that new products are capable of being inspected and validated with the existing technical pool's resources.
· Technical QC Oversight: Provide structural and technical oversight to the Quality Control (QC) vertical, resolving floor quality issues and improving inspection gauging efficiencies.
· Regulatory Submission Support: Manage technical file inputs, regulatory requests, and technical file integrity to support global market readiness.
· Tooling & Equipment Handover: The QE must act as the "Gatekeeper" for Tooling Acceptance, ensuring that any new or repaired mold or auxiliary equipment has a completed and verified validation package before being released to the production floor.
· Training & Competency: Perform technical training for Quality Assurance Technicians (QATs) and serve as a Subject Matter Expert (SME) for hands-on competency assessments.
Requirements
· Bachelor’s degree in engineering or related field or 3-10 years of direct experience in a quality engineering role at a in a medical device environment.
· Minimum 4–7 years of experience specifically within a medical device or highly regulated FDA environment.
· Expert understanding of FDA 21 CFR 820, ISO 13485, GD&T, and MSA.
· Proficiency in Minitab, Solidworks, MS suite, ERP and eQMS systems.
· Requirements: Ability to lift up to 60 lbs. and travel between local facilities for technical deployment.
· Excellent communication, time management and organizational skills.
· Ability to manage multiple priorities.
· Must be able to function well in a team-oriented environment.
· Flexibility to work additional hours when needed.
· Continuous improvement mindset.
Compensation: $100,000+