Quality Systems Specialist

Quality Systems Specialist (ISO 9001 / ISO 13485)Location: Sussex, WI Pay: $65,000 - $80,000 (Based on Experience) Shift: 1st Shift (8:00 AM - 4:00 PM, Flexible) Status: Direct-Hire | 100% On-Site Engauge is seeking an experienced Quality Systems Specialist to support and continuously improve the Quality Management System (QMS) within a manufacturing environment. Plastics manufacturing experience is preferred but not required. Strong ISO 9001 experience is required; ISO 13485 exposure is a plus. Position Summary The Quality Systems Specialist will maintain and enhance the company's QMS in compliance with ISO 9001:2015 and ISO 13485:2016 standards. This role supports audits, CAPA processes, document control, ERP quality modules (IQMS), and customer-facing quality initiatives. Key Responsibilities Sustain and improve the Quality Management System Lead Internal and Surveillance Audits (ISO 9001 & ISO 13485) Prepare for certification, regulatory, and customer audits Manage and reduce CAPA backlog; conduct root cause analysis Administer document control and support Engineering Change Notices (ECNs) Utilize ERP system (IQMS) to collect and analyze quality data Serve as liaison between customers and the Quality Department Support Management Review and continuous improvement initiatives Promote safe, compliant 5S work practices Required Qualifications Bachelor's degree in Quality, Engineering, or related field (or equivalent experience) 3-7 years of experience in a quality systems role within an ISO-certified or regulated environment Strong working knowledge of ISO 9001:2015 Experience with internal auditing, document control, and CAPA processes Certified Internal Auditor (ISO 9001 and/or ISO 13485) Preferred Qualifications ISO 13485:2016 experience Plastics manufacturing experience ERP/QMS experience (IQMS preferred) ASQ certification Knowledge of FDA regulations (21 CFR Part 820 / GMP) Key Skills Strong attention to detail and documentation accuracy Excellent communication skills Analytical, risk-based problem-solving mindset Ability to manage multiple priorities Proactive approach to continuous improvement If interested, text Caleb at (586) 356-3251 or email your resume to .

Created: 2026-03-04