Overview
Quality Engineer Jobs in South Royalton, VT at Nolato
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 both 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.
Core 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 drifts into a 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 actually 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.
Qualifications & Skills
-Education & Experience: * Bachelor’s degree in Engineering or Science OR 4–7 years of direct experience in the Quality Engineering medical device field.
-Experience: Minimum 4–7 years of experience specifically within a medical device or highly regulated FDA environment.
-Knowledge: Expert understanding of FDA 21 CFR 820, ISO 13485, GD&T, and MSA.
-Tools: 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.
-Professional appearance.
-Must have a continuous improvement mindset.
Job Type: Full-time
Pay: $75,000.00 – $110,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
People with a criminal record are encouraged to apply
Experience:
- medical device or highly regulated FDA environment: 4 years (Required)
- expert knowledge of FDA 21 CFR 820, ISO 13485, GD&T, MSA: 4 years (Required)
Ability to Relocate:
- South Royalton, VT 05068: Relocate before starting work (Required)
Work Location: In person
Title: Quality Engineer
Company: Nolato
Location: South Royalton, VT
Category:
