Quality Systems Engineer

Mack Molding•Arlington, VT

About The Position

The Quality Systems Engineer supports the Quality Assurance Manager in maintaining, monitoring, and continually improving the Mack Northern Division quality management system to ensure ongoing compliance with ISO 9001, ISO 13485, AS9100, and applicable customer and regulatory requirements. The role coordinates and conducts internal audits; supports registrar, Notified Body, customer, and regulatory audits; drives corrective action closure; works with Document Control; supports quality and quality-system training for new hires; and supervises the Quality Technician – Quality Assurance. The position supports quality-system requirements specific to AS9100 and ISO 13485, including counterfeit parts and foreign object debris prevention, configuration management, product safety awareness, medical-device risk management, complaint handling, records, and traceability. It also supports Computer Software Assurance activities for software used as part of or in support of the quality management system. The role collects and reports quality-system metrics, contributes data to Management Review, and drives continuous improvement while working constructively with internal departments, facilities, business units, and customers.

Requirements

Minimum education: Associate’s degree.
Four to six years of experience in an ISO 9001, ISO 13485, and/or AS9100 Quality System environment when meeting the minimum education requirement.
Internal auditing experience is required.
Working knowledge of applicable ISO 9001, ISO 13485, and AS9100 requirements.
Bachelor’s degree in Engineering or a related technical discipline, together with two to four years of experience in an ISO 9001, ISO 13485, and/or AS9100 Quality System environment, is preferred.

Nice To Haves

Bachelor’s degree in Engineering or a related technical discipline.
Experience supporting registrar or customer audits.

Responsibilities

Maintain the quality management system in compliance with ISO 9001, ISO 13485, AS9100, and applicable customer and regulatory requirements.
Monitor revisions to relevant standards, perform gap assessments, and support implementation of required system changes.
Plan, schedule, and conduct internal audits; track findings through verified closure.
Support preparation for, hosting of, and responses to registrar, Notified Body, customer, and regulatory audits.
Prepare audit responses and objective evidence, and track external-audit corrective actions through closure within required timeframes.
Administer the CAPA process, facilitate root cause analysis, and verify corrective-action effectiveness.
Monitor ageing of problem reports, including CCRs, NMRs, and NCRs, and support timely closure.
Work with Document Control to review, author, and revise procedures, work instructions, and forms; support the Agile Document Management System.
Ensure quality records are controlled, retained, and retrievable in accordance with applicable standards and customer requirements.
Support AS9100 requirements, including counterfeit parts prevention, FOD prevention, configuration management, key characteristics, and product safety awareness.
Support ISO 13485 requirements, including ISO 14971 risk management, medical-device or batch records, complaint handling, and product traceability.
Support Computer Software Assurance activities for software used as part of or in support of the quality management system, in accordance with ISO 13485 and 21 CFR Part 820.
Collect, analyze, and report quality-system metrics and prepare data and inputs for Management Review.
Support Quality and Quality System training, including standards training for new hires, and maintain related training records.
Supervise the Quality Technician – Quality Assurance.
Maintain constructive working relationships and effective communication with business units, customers, and internal departments.
Drive continuous improvement of quality-system processes.
Work with other departments and facilities to meet departmental goals and customer demands.
Perform other duties as assigned.