Quality Operations Specialist

GILERO • Pittsboro, NC

2d • Onsite

About The Position

Gilero, a Sanner Group company, is seeking an experienced Quality Operations Specialist to support our Pittsboro, NC facility. You will be responsible for Quality Operations to support transition between development and commercial manufacturing activities. This role is crucial in bridging the gap between product development and manufacturing, ensuring compliance and smooth transitions for innovative medical devices and drug delivery products.

Requirements

• Bachelor’s degree or equivalent combination of education and experience.
• 0 - 5 years in regulated manufacturing environment
• Experience with FDA 820 CFRs/ISO 13485/cGMP quality management system requirements and medical devices/combination product development
• Basic experience with coordination of GMP compliant Documents, Records, and Training
• Strong written and verbal communication skills
• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Nice To Haves

• 5+ years in medical device manufacturing
• Experience with quality operations, design transfer and GxP concepts
• Experience with GMP manufacturing operations and process development
• ASQ or related certification

Responsibilities

• Liaise between product development and manufacturing project teams to ensure compliant design transfer
• Coordinate, assemble, and route documentation per quality system lifecycle requirements
• Perform incoming inspection/testing and release of accepted materials
• Perform pilot builds in cooperation with operations and design transfer teams
• Conduct labeling verification in accordance with product requirements
• Perform in-process testing and QA inspections per product requirements
• Coordinate environmental monitoring, including particle counts and temperature/humidity/pressure measurements
• Coordinate cleaning of controlled environment areas per internal procedures
• Manage third-party environmental testing and approve results
• Support sterilization coordination
• Review batch records for accuracy and completeness. Collaborate with manufacturing and development teams to resolve any batch documentation-related errors or gaps
• Support quality event initiation and investigation for nonconformances, CAPA, change control and complaints.
• Support continuous improvement projects and audits

Benefits

• Annual bonus plan
• Medical (3 BCBS plans to choose from)
• Dental and vision
• Company provided life insurance
• Short-term and long-term disability
• 401(k) with a match the first month after you start with a zero-vesting period
• Access to LinkedIn learning for personal and professional development
• Competitive base salary plus incentive compensation
• Annual performance bonus
• Paid parental leave
• Paid Time Off and company holidays
• Career growth opportunities within Gilero and the global Sanner Group

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level