Quality Systems Specialist – Medical Devices & Compliance

BioHorizons; Hoover, Northern (AL, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

BioHorizons in Hoover, AL seeks a Quality Specialist to uphold our Quality Management System, inspect devices, and maintain device history records. The role supports calibration and training activities while ensuring compliance with regulatory expectations.

The candidate will assist with MRB processes, nonconforming materials handling, and verification of documentation, with travel kept under 10% for audits and training. Bachelor’s degree preferred and a strong eye for detail are essential.

Qualifications

• High School graduate required; Bachelor’s degree preferred.
• Minimum 3+ years in a medical device manufacturing environment.
• Knowledge of ISO13485 and 21 CFR Part 820/11 is preferred.
• Ability to read blueprints and use precision measuring tools.
• Strong communication and detail-oriented work ethic.

Responsibilities

• Implement and maintain the Quality Management System.
• Inspect device components and finished devices per procedures.
• Review and maintain device history records and documentation.
• Support nonconforming materials and MRB activities.
• Assist with calibration and recordkeeping for instruments.
• Support training activities and process validations.
• Travel up to 10% for training and audits.

Skills

Blueprint Reading

Precision Instruments

ISO13485 familiarity

Document Control

Regulatory Awareness

Communication Skills

Independent Judgment

Education

High School Diploma

Bachelor’s Degree preferred

Tools

Calipers

Micrometers

Gauges

Optical Comparators

GD&T

Job description

BioHorizons in Hoover, AL seeks a Quality Specialist to uphold our Quality Management System, inspect devices, and maintain device history records. The role supports calibration and training activities while ensuring compliance with regulatory expectations.

The candidate will assist with MRB processes, nonconforming materials handling, and verification of documentation, with travel kept under 10% for audits and training. Bachelor’s degree preferred and a strong eye for detail are essential.