Lead the development, implementation, and continuous improvement of an ISO 9001-compliant Quality Management System (QMS) while owning key Supplier Quality activities. This role builds the foundational processes, documentation, audit cadence, and performance metrics required for certification and sustained compliance. Partners with Manufacturing, Engineering, and Supply Chain to ensure products and purchased components meet requirements and drives corrective actions and risk-based improvements across the business.
Responsibilities
Develop, implement, and maintain an ISO 9001-compliant Quality Management System (QMS), including the quality manual/structure, process interactions, and required documented information.
Lead QMS gap assessments and create an implementation roadmap to achieve certification readiness; track actions, owners, and timelines.
Establish and manage document control: procedures, work instructions, forms, records retention, revision control, and change management.
Create and run the internal audit program (audit schedule, auditor training, checklists, reporting); ensure corrective actions are completed and verified for effectiveness.
Facilitate Management Review: compile KPIs, audit results, customer/supplier issues, risks/opportunities, and improvement actions; document outputs and follow-up.
Support external audits and certification activities: coordinate with registrar, prepare evidence packages, host audits, and close findings.
Own Supplier Quality: supplier qualification/onboarding requirements, supplier performance metrics (PPM, escapes, on-time delivery), and supplier development plans.
Plan and execute supplier audits and process assessments; drive corrective actions and verify implementation.
Lead nonconformance and corrective action processes (NCR/MRB, containment, 8D/A3, 5-Why/Fishbone) for supplier and internal issues, including effectiveness checks.
Develop and maintain incoming inspection plans, sampling plans, and acceptance criteria; support receiving inspection and disposition of nonconforming material.
Drive data-based improvement using quality tools (SPC, MSA, capability, trend analysis); build dashboards for internal and supplier performance.
Support NPI and engineering changes by ensuring controls are defined (critical characteristics, inspection/control plans) and supplier readiness is achieved before launch.
Qualifications
5+ years of Quality Engineering experience in a manufacturing environment, including hands-on Supplier Quality responsibility.
Demonstrated experience developing and implementing an ISO 9001 (or similar) Quality Management System, ideally through certification (or leading major QMS buildout/gap-closure efforts).
Working knowledge of ISO 9001 requirements (risk-based thinking, documented information, internal audits, management review, corrective action, continual improvement).
Internal Auditor training required; ISO 9001 Lead Auditor certification strongly preferred.
Bachelor’s degree in engineering, Quality, or related field (or equivalent experience).
Strong skills in document control, process mapping, procedure/work instruction development, and cross-functional training/rollout.
Proven corrective action leadership using structured problem solving (8D/A3, 5-Why, Fishbone) with verification of effectiveness.
Strong understanding of inspection methods, metrology, GD&T, and ability to read and interpret engineering drawings/schematics.
Experience with statistical tools and quality methods (SPC, MSA, capability studies, sampling plans).