Quality Assurance Operations Lead, Medical Devices

Company: Avalign Technologies
Location: Mentor
Posted on: April 5, 2026

Job Description:

Lead Quality Forward at Avalign At Avalign, we design, engineer, and manufacture innovative, high-performance medical devices that make a tangible difference for clinicians and their patients. We’re growing fast, we’re inventive, and we rally around meeting every customer’s quality specification—every time. A Day in Your Role You start the day guiding a tight-knit quality crew—inspectors, calibration specialists, and document control—aligning priorities to support that day’s shipments in our ERP. You scan first pass yield (FPY) trends, update the nonconforming material report (NCMR) log, and make sure training records match the latest revisions. Coffee in hand, you huddle with the Quality Manager to schedule time off, discuss performance reviews, and resolve personnel items, then sync with production and engineering to keep quality data flowing and actions on track. Midday, you’re on the floor, confirming general housekeeping keeps the area organized and safe, and you’re coaching on inspection methods and GD&T interpretation. You’re continuously looking for better ways to run—refining processes and systems, ensuring our area adheres to company policies, procedures, ISO 13485, and 21 CFR 820. By afternoon, you’ve logged internal and external quality data, communicated updates across departments, and closed the loop with your team to sustain a cohesive, high-performing environment. How You’ll Make an Impact Provide hands-on leadership for inspectors, calibration, and document control to meet daily shipping needs from the ERP schedule. Keep department training completed and current to the latest revision. Record and report first pass yield (FPY) metrics. Maintain the nonconforming material report (NCMR) log and all supporting documentation. Uphold an organized, safe workspace through strong housekeeping practices. Monitor and log internal/external quality data tied to quality performance and drive improvements. Partner with the Quality Manager on personnel matters: time off coordination, performance reviews, and disciplinary actions. Ensure conformance to company policies, procedures, and applicable regulations. Foster open communication with the Quality Manager, peers, and other departments to keep a cohesive team rhythm. What You Bring Ability to read and interpret blueprints; working knowledge of GD&T and inspection methods. 2–5 years of related experience preferred, not required. Understanding of ISO 13485 and 21 CFR 820. Clear, professional communication skills and a courteous, collaborative style. Who Thrives Here A self-starter energized by a fast-paced environment. A quick learner eager to deepen knowledge of manufacturing processes. Reliable, accountable, and present when it counts. Team-oriented with an open, positive approach to assignments. Someone who can plan and execute across teams. An effective written and verbal communicator. Tools & Proficiencies Proficiencies: GD&T, Quality Inspection, Quality Control, Advanced Inspection & Gauge Measurement, Blueprint Reading. Equipment: Measurement gauges, calipers, and micrometers. Why You’ll Love Working Here Competitive pay with a full benefits package. Comprehensive medical, dental, and vision insurance. Paid vacation plus 10 paid holidays annually. Employer-funded Basic Life and AD&D, STD, and LTD insurance. Tuition reimbursement for continued learning. Great 401(k) with company match. Generous employee referral bonuses. Performance-based culture with real opportunities to advance. Temperature-controlled environment. Community involvement and giving back initiatives. Extras like travel assistance, EAP, and more. What You Won’t Experience Feeling stuck—there are strong pathways to grow and learn. Monotony—our product variety keeps every day fresh. Being just a number—we’re close-knit and support one another.

Keywords: Avalign Technologies, Mansfield , Quality Assurance Operations Lead, Medical Devices, Engineering , Mentor, Ohio