Quality Systems Engineer

Summary:
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, and AS9100 requirements. Coordinates and performs internal audits, supports registrar, customer and regulatory audits, drives corrective action closure, works with Document Control, supports Quality and Quality System training of new hires, and supervises the Quality Technician – Quality Assurance.

Essential Duties and Responsibilities
include the following:

• Maintains the quality management system in compliance with ISO 9001, ISO 13485, and AS9100 requirements, as well as applicable customer and regulatory requirements


• Monitors revisions to ISO 9001, ISO 13485, AS9100, and related standards; performs gap assessments and supports implementation of required system changes


• Plans, schedules, and conducts internal audits in accordance with the Mack Northern Division internal audit program; tracks audit findings through verified closure


• Supports the Quality Assurance Manager in preparing for, hosting, and responding to registrar, Notified Body, customer, and regulatory audits


• Prepares audit responses and objective evidence; tracks corrective actions resulting from external audits to closure within required timeframes


• Administers the CAPA process, including facilitating root cause analysis (e.g. 5 Why, Fishbone, 8D) and verifying the effectiveness of corrective actions


• Monitors problem report (i.e. CCRs, NMRs, NCRs, etc.) ageing and supports timely closure to fulfill related metrics


• Works with Document Control to review, author, and revise procedures, work instructions, and forms to ensure compliance with applicable standards; supports the Agile Document Management System


• Ensures quality records are properly controlled, retained, and retrievable in accordance with applicable standards and customer requirements


• Supports AS9100-specific requirements, including counterfeit parts prevention, FOD prevention, configuration management, key characteristics, and product safety awareness


• Supports ISO 13485-specific requirements, including risk management (ISO 14971), records for each medical device or batch, complaint handling, and product traceability


• Supports 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


• Collects, analyzes, and reports quality system metrics, and prepares data and inputs for Management Review


• Supports Quality training and Quality System training, including ISO 9001, ISO 13485, and AS9100 training of new hires; maintains related training records


• Supervises the Quality Technician – Quality Assurance


• Maintains constructive working relationship with business units, customers, and internal departments including effective communication


• Drives continuous improvement of quality system processes


• Works closely with other departments and facilities to successfully meet departmental goals and customer demands


• Other duties as assigned

Education/Experience:

Bachelor’s degree (B.S.) preferred in Engineering or a related technical discipline, plus two to four years’ experience in an ISO 9001, ISO 13485, and/or AS9100 Quality System environment. Minimum education requirements include an Associate’s degree, plus four to six years’ experience in an ISO 9001, ISO 13485, and/or AS9100 Quality System environment. Internal auditing experience required; experience supporting registrar or customer audits preferred.