Quality Assurance Operations Lead, Medical Devices

Avalign Technologies•Mentor, OH

16d

About The Position

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.

Requirements

Ability to read and interpret blueprints; working knowledge of GD&T and inspection methods.
Understanding of ISO 13485 and 21 CFR 820.
Clear, professional communication skills and a courteous, collaborative style.

Nice To Haves

2–5 years of related experience preferred, not required.

Responsibilities

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.