Description
Position Overview
We are seeking a detail-oriented Quality Control Administrator to join a regulated manufacturing environment. This position is ideal for someone who enjoys reviewing documentation, ensuring accuracy, and supporting quality processes that help deliver compliant, high-quality products.
In this role, you will review manufacturing documentation, inspect product labeling, verify test data, and ensure all records meet ISO 13485 and FDA regulatory requirements. This is an excellent opportunity for someone with strong attention to detail and experience working in a regulated manufacturing environment.
Key Responsibilities
Proofread and review manufacturing documentation for accuracy and completeness.
Perform Device History Record (DHR) reviews for production and returned service (RGA) products.
Inspect and verify product labels for accuracy and compliance.
Review product test data sheets and supporting quality documentation.
Generate Certificates of Conformance (CoC) for finished products.
Perform final quality documentation review prior to product shipment.
Review sterilization records and supporting documentation for compliance.
Review documentation for returned serviced goods.
Follow Standard Operating Procedures (SOPs), quality policies, and regulatory requirements.
Maintain accurate records while ensuring compliance with ISO 13485 and FDA regulations.
Support continuous improvement initiatives and special projects as assigned.
Maintain a safe, organized, and compliant work environment.
Qualifications
3–5 years of experience in a regulated manufacturing environment.
Experience with ISO 13485 and/or medical device manufacturing is highly preferred.
Experience working with serialized products, product traceability, or manufacturing documentation.
Strong attention to detail with the ability to identify documentation errors and inconsistencies.
Comfortable working in a manufacturing environment while supporting office-based quality functions.
Excellent organizational and time management skills.
Strong written and verbal communication skills.
Ability to work independently and collaborate with cross-functional teams.
Strong problem-solving skills and a commitment to quality and compliance.
Preferred Experience
Medical device, pharmaceutical, or other regulated manufacturing experience.
Experience reviewing Device History Records (DHRs), batch records, or quality documentation.
Familiarity with FDA regulations and ISO 13485 quality systems.
Experience reviewing returned serviced goods (RGA) documentation.
Experience proofreading technical or manufacturing documents.
Physical Requirements
Primarily office-based with frequent interaction on the manufacturing floor.
Ability to sit and work at a computer for extended periods.
Ability to stand and walk throughout the facility as needed.
Ability to occasionally lift up to 40 pounds.