Quality Specialist – Medical Devices (Design Transfer & QA)

NCBioImpact; North Carolina; Sur place; USD 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Annual bonus plan

BCBS medical plans

Dental and vision coverage

Company-provided life insurance

Short- and long-term disability

Paid maternity and parental leave

401(k) match

LinkedIn Learning access

Résumé du poste

Sanner America, headquartered in Durham, NC, is seeking a Quality Specialist to support the Pittsboro, NC facility. You will bridge development and manufacturing for medical devices and drug delivery products, ensuring quality excellence and regulatory alignment.

This role involves coordinating documentation, inspections, testing, environmental monitoring, and CAPA activities, with opportunities for growth and training in a fast-paced environment.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• 1 - 3 years in regulated manufacturing environment.
• Experience with FDA 820 CFRs/ISO 13485/cGMP quality management system requirements for medical devices.
• Basic experience coordinating GMP compliant documents, records, and training.
• Strong written and verbal communication skills.

Responsabilités

• 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 temp/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; resolve documentation gaps with teams.
• Support quality event initiation and investigation for nonconformances, CAPA, change control and complaints.
• Support continuous improvement projects and audits.

Connaissances

Regulatory compliance

Quality documentation

Communication skills

GxP concepts

QA inspections

Formation

Bachelor’s degree or equivalent

Description du poste

Sanner America, headquartered in Durham, NC, is seeking a Quality Specialist to support the Pittsboro, NC facility. You will bridge development and manufacturing for medical devices and drug delivery products, ensuring quality excellence and regulatory alignment.

This role involves coordinating documentation, inspections, testing, environmental monitoring, and CAPA activities, with opportunities for growth and training in a fast-paced environment.