Hiring: Quality Manager Company: Angel Aligner Location: Oak Creek, WI Job Posted Time: 2026-09-10 10:44:10 Target Skills & Keywords : Microsoft Office, Quality Assurance, Root Cause Analysis, Six Sigma About the job Experience: •3+ years of experience in quality assurance within medical device, pharmaceutical, or regulated manufacturing. •1+ years of leadership or supervisory experience. Required Skills: •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. Qualifications: •Bachelor’s degree in Quality, Engineering, Life Sciences, or related field preferred; equivalent experience accepted. •Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP principles. •Proficiency with eQMS systems and Microsoft Office. •Strong communication, coaching, and conflict‑resolution skills. •Demonstrated capacity to interpret engineering drawings, specifications, and inspection standards. •, orthodontics, dental devices, or custom‑manufactured devices. •ASQ CQE, CQA, or Six Sigma certification. •Operational familiarity with electronic QMS systems (e.g., MasterControl, Greenlight Guru). Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!