Quality Engineer/Internal Auditor
4900 Bethania Station Road Winston Salem, NC 27105 US
Job Description
Location: Winston-Salem, NC
Contract Length: 12 Months
Start Date: ASAP
Industry: Medical Devices / Quality Engineering
About the Role:
We are seeking a highly motivated Quality Engineer / Internal Auditor to join our team on a 12-month contract basis. This is a hybrid role with a requirement to be onsite 1–3 days per week, and 3 days a week during the first three weeks for onboarding and training.
As a Quality Engineer, you will play a critical role in ensuring our processes and products meet the highest quality standards, with a strong focus on ISO 13485 compliance. Ideal candidates will have a solid background in quality engineering and internal auditing within a regulated industry, preferably medical devices.
Key Responsibilities:
- Perform internal audits and quality engineering tasks to support compliance with ISO 13485 and other applicable standards.
- Participate in risk management, CAPA investigations, and continuous improvement initiatives.
- Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
- Support regulatory and customer audits as needed.
- Maintain and improve quality system documentation and records.
- Bachelor’s degree in Engineering or a related technical field (required).
- Minimum of 5 years of experience in quality engineering within a regulated industry.
- Strong understanding of ISO 13485 and quality system regulations.
- Lead Auditor certification for ISO 13485 (preferred).
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Duration: 12 months
- Location: Hybrid – onsite presence required 1–3 days/week, including 3 days/week onsite during initial training (first 3 weeks)
- Compensation: Competitive and commensurate with experience
If you're a detail-oriented quality professional with auditing experience and a passion for excellence, we’d love to hear from you.
Email your resume to jyeargan@theresource.com.
Â
