Senior Quality Engineer — Med Devices, CAPA & Audits

Sanner America (formerly Gilero); Pittsboro (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental

Vision

Life insurance

Disability insurance

401(k) with match

LinkedIn Learning

Job summary

Sanner America (formerly Gilero) seeks a Quality Engineer to ensure medical device and combination product quality. You will oversee supplier management, drive CAPA, change control, internal and external audits, and support development through production.

Based in Durham or Pittsboro with hybrid options, you will collaborate across teams to improve processes, maintain GMP/GxP compliance, and release quality system documents while building robust traceability.

Qualifications

• Bachelor's degree in engineering, science or relevant field is required.
• Minimum 5 years quality experience in regulated manufacturing or development.
• FDA 820 CFRs/ISO 13485/cGMP knowledge required.
• Experience with risk analysis and continuous improvement concepts.
• Experience leading or supporting audits.

Responsibilities

• Drive continuous improvement in quality and production processes.
• Manage and improve CAPA, complaints, supplier management and audits.
• Initiate, investigate and close quality events and change controls.
• Facilitate root cause investigations and identify failure modes.
• Author and revise procedures, train staff, release QMS documents.
• Support internal and external audits, including customer and supplier.
• Represent quality in product development and maintain traceability.

Skills

Quality system knowledge

Audit experience

Problem-solving

Written communication

Cross-functional collaboration

Education

Bachelor's degree in engineering, science, or relevant field

Master's degree (preferred)

Tools

GxP fundamentals

Regulatory knowledge (FDA 820 CFRs, ISO 13485)

Job description

Sanner America (formerly Gilero) seeks a Quality Engineer to ensure medical device and combination product quality. You will oversee supplier management, drive CAPA, change control, internal and external audits, and support development through production.

Based in Durham or Pittsboro with hybrid options, you will collaborate across teams to improve processes, maintain GMP/GxP compliance, and release quality system documents while building robust traceability.