Hybrid Quality Engineer - Medical Devices & CI

Sanner America (formerly Gilero); Durham (NC); Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

Annual bonus plan

Medical insurance (BCBS)

Dental and vision insurance

Company-provided life insurance

Short-term & long-term disability

401(k) with match

LinkedIn Learning access

Job summary

Gilero, a Sanner Group company, seeks a Quality Engineer to oversee supplier management and drive continuous improvement across quality systems for medical devices. Hybrid work is available, with base in Durham or Pittsboro, NC.

You will support design, development, and production while ensuring products meet high quality standards. Responsibilities include leading CAPA processes, investigations, change control, and audits, plus authoring procedures and training team members.

Qualifications

• Bachelor’s degree in engineering, science, or relevant field.
• Minimum 5 years quality experience in a regulated manufacturing or development environment.
• Proficiency with FDA 820 CFRs, ISO 13485, and cGMP for medical devices.
• Experience with risk analysis and continuous improvement concepts.
• Extensive experience with GxP requirements.
• Strong technical written and verbal communication skills.
• Experience leading and/or supporting audits.
• Excellent interpersonal, change management, planning and organizational skills.
• Excellent oral, written, and presentation communication skills.

Responsibilities

• Drive continuous improvement in quality and production processes by identifying opportunities and developing action plans.
• Manage, trend, and improve CAPA, complaints, supplier management, and external audits.
• Execute quality event initiation, investigation, and closure for nonconformances, CAPA, changes and complaints; perform effectiveness checks.
• Facilitate investigations to determine root cause and failure modes.
• Author new or revised procedures, train team members and release quality system procedures.
• Support internal and external audits including customer and supplier audits.
• Represent the quality function in product development projects and author DHF documents.
• Ensure compliant project documentation with traceability and controls hierarchy.
• Investigate, disposition, and resolve nonconforming material events during development and production phases.
• Maintain quality records, summarize data, and report quality metrics.

Skills

Quality experience

Auditing

Communication

Risk analysis

GxP knowledge

Education

Bachelor's degree in engineering or science

Job description

Gilero, a Sanner Group company, seeks a Quality Engineer to oversee supplier management and drive continuous improvement across quality systems for medical devices. Hybrid work is available, with base in Durham or Pittsboro, NC.

You will support design, development, and production while ensuring products meet high quality standards. Responsibilities include leading CAPA processes, investigations, change control, and audits, plus authoring procedures and training team members.