Senior Design Quality Engineer – Medical Devices

Gilero; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental & Vision

Life insurance

Disability insurance

401(k) match

LinkedIn Learning

Job summary

Gilero, a Sanner Company, in Durham, NC, seeks a Senior Design Quality Engineer to guide quality during ideation through transfer to manufacturing of medical devices and combination products. You will lead risk management, define requirements, and shape verification and validation strategies, partnering with cross-functional teams to ensure patient safety and regulatory compliance.

You will collaborate across disciplines to ensure products meet the highest standards and support audits, CAPA, and

Qualifications

• Bachelor's degree in engineering or a related field.
• 5+ years of relevant work experience in medical device quality.
• Proficiency with FDA 820 CFRs, ISO 13485 and cGMP requirements.
• Strong knowledge of ISO 14971 risk management.
• Experience with design history file and design transfer processes.

Responsibilities

• Represent Quality in cross-functional development teams through transfer to production.
• Author and maintain DHF documents ensuring ISO 13485 compliance.
• Translate user needs and regulatory inputs into measurable requirements.
• Support design verification and validation activities using statistical approaches.
• Support CAPA, complaints, supplier management and internal audits.
• Lead risk management activities including FMEAs per ISO 14971.
• Ensure traceability of design requirements and risk controls.
• Assist manufacturing transfer and process validation planning.
• Investigate nonconforming material events and drive corrective actions.
• Contribute to QMS procedures and train team members as needed.
• Support supplier qualification and ongoing audits.
• Facilitate root-cause investigations and issue resolution.

Skills

Cross-functional collaboration

Risk management

Regulatory compliance

Statistical methods

Quality systems

Education

Bachelor's degree in engineering

Tools

FDA 820 CFRs

ISO 13485

ISO 14971

Job description

Gilero, a Sanner Company, in Durham, NC, seeks a Senior Design Quality Engineer to guide quality during ideation through transfer to manufacturing of medical devices and combination products. You will lead risk management, define requirements, and shape verification and validation strategies, partnering with cross-functional teams to ensure patient safety and regulatory compliance.

You will collaborate across disciplines to ensure products meet the highest standards and support audits, CAPA, and