Quality Manager

We’re a New State of the Art Technology Manufacturing Plant in Oak Creek, WI! Job Summary: The Quality Manager leads daily quality operations within a medical device manufacturing environment, ensuring products, processes, and documentation meet FDA, ISO 13485, and internal quality system requirements. This role oversees quality inspectors/technicians, supports production teams, drives compliance, and ensures consistent product quality and audit readiness. Essential Functions: Manages a team of quality inspectors and quality technicians, including scheduling, training, and performance management. Ensures in-process and final inspections are completed accurately and on time. Reviews and approves inspection records, device history records (DHRs), and nonconformance reports. Supports investigations, root cause analysis, and CAPA activities. Monitors production quality trends and escalates issues proactively. Ensures compliance with FDA 21 CFR Part 820, ISO 13485, and internal SOPs. Supports internal and external audits by preparing documentation and leading inspection activities. Collaborates with manufacturing, engineering, and regulatory teams to resolve quality issues. Oversees calibration, equipment checks, and quality-related preventive maintenance. Trains employees on quality procedures, inspection methods, and documentation requirements. Drives continuous improvement initiatives to reduce defects and improve process capability. Ensures proper handling, segregation, and disposition of nonconforming material. Qualifications: Bachelor’s degree in Quality, Engineering, Life Sciences, or related field preferred; equivalent experience accepted. 3+ years of experience in quality assurance within medical device, pharmaceutical, or regulated manufacturing. 1+ years of leadership or supervisory experience. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP principles. Experience with inspection tools, measurement systems, and quality documentation. Proficiency with eQMS systems and Microsoft Office. Strong communication, coaching, and conflict-resolution skills. Ability to interpret engineering drawings, specifications, and inspection standards. Preferred but not required Qualifications: Experience in clear aligners, orthodontics, dental devices, or custom-manufactured devices. ASQ CQE, CQA, or Six Sigma certification. Experience with 3D printing, thermoforming, or digital manufacturing workflows. Familiarity with electronic QMS systems (e.g., MasterControl, Greenlight Guru). Experience supporting FDA inspections or notified‑body audits. Leadership and team development Root cause analysis and problem solving Strong documentation and organizational skills Decision-making in fast-paced environments High attention to detail and compliance focus Physical and Work Environment Requirements: Ability to work in manufacturing, cleanroom, and inspection areas. Ability to stand, walk, and lift up to 30-40 lbs as needed. Use of PPE as required (gloves, safety glasses, cleanroom attire). Occasional overtime during audits, investigations, or production surges. We offer a competitive base salary and benefits. Standard workweek with occasional off-shift support. #J-18808-Ljbffr Angel Aligner