Quality Operations Specialist — Medical Devices

Gilero, A Sanner Group Company; Pittsboro (NC); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision insurance

Life insurance

Disability coverage

401(k) with company match

Paid parental leave

Paid Time Off

LinkedIn Learning

Career growth opportunities

Job summary

Gilero, a Sanner Group company, seeks an experienced Quality Operations Specialist to support its Pittsboro, NC facility, bridging development and commercial manufacturing. You will oversee quality operations during transitions and coordinate cross-functional activities to ensure compliant products.

Responsibilities include document control, environmental monitoring, QA inspections, and batch record reviews.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• 0–5 years in a regulated manufacturing environment.
• Experience with FDA 21 CFR 820, ISO 13485, and cGMP in medical devices.
• Coordinate GMP documents, records, and training.
• Strong written and verbal communication skills.

Responsibilities

• Liaise between product development and manufacturing to ensure compliant design transfer.
• Coordinate and route documents per quality system lifecycle requirements.
• Perform incoming inspection/testing and release of materials.
• Support QA inspections and review batch records for accuracy.
• Coordinate environmental monitoring and cleaning of controlled areas.
• Support audits, CAPA investigations, and continuous improvement.

Skills

FDA/ISO quality systems

Documentation coordination

Design transfer

GxP concepts

Communication skills

Education

Bachelor's degree or equivalent

ASQ certification (preferred)

Job description

Gilero, a Sanner Group company, seeks an experienced Quality Operations Specialist to support its Pittsboro, NC facility, bridging development and commercial manufacturing. You will oversee quality operations during transitions and coordinate cross-functional activities to ensure compliant products.

Responsibilities include document control, environmental monitoring, QA inspections, and batch record reviews.