Quality Operations Specialist - Medical Devices

Gilero; Chicago, Northern (IL, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, and vision insurance

Life insurance

Disability insurance

401(k) with match

Paid parental leave

Paid time off and holidays

LinkedIn Learning

Job summary

Gilero is seeking a Quality Operations Specialist to support our Pittsboro, NC facility, bridging development and commercial manufacturing. You will coordinate documentation, perform inspections, and participate in environmental monitoring and release activities for medical devices and drug delivery products.

The role requires FDA 820 CFRs/ISO 13485 knowledge, strong communication, and collaboration with cross-functional teams to ensure compliance and continuous improvement within a fast-paced

Qualifications

• Bachelor’s degree or equivalent in a related field.
• Experience with FDA 820 CFRs/ISO 13485/cGMP requirements for medical devices.

Responsibilities

• Liaise between development and manufacturing for design transfer.
• Coordinate documentation per quality system lifecycle requirements.
• Perform incoming inspection/testing and release of materials.
• Conduct labeling verification and in-process QA inspections.
• Coordinate environmental monitoring (particle counts, temp/humidity/pressure).
• Review batch records and resolve documentation gaps with teams.
• Support CAPA, change control, and quality events.

Skills

GxP knowledge

Quality operations

Design transfer

Documentation coordination

Communication skills

Regulated manufacturing

Problem solving

Education

Bachelor’s degree or equivalent

ASQ certification

Tools

Quality Management System

Job description

Gilero is seeking a Quality Operations Specialist to support our Pittsboro, NC facility, bridging development and commercial manufacturing. You will coordinate documentation, perform inspections, and participate in environmental monitoring and release activities for medical devices and drug delivery products.

The role requires FDA 820 CFRs/ISO 13485 knowledge, strong communication, and collaboration with cross-functional teams to ensure compliance and continuous improvement within a fast-paced