Quality Engineer — Drive CAPA, Compliance & Process Improvement

Charter Medical; Winston-Salem (NC); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(k) with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Discount

Job summary

Charter Medical is seeking a Quality Engineer to support the Quality Management System in alignment with FDA 21 CFR Parts 210, 211 and 820 and ISO 13485:2016. The role focuses on customer complaints, CAPAs, audits, and continuous improvement to ensure product quality and regulatory compliance.

The position is 1st shift, Monday–Friday, with opportunities to lead CAPA activities and coordinate external audits across two Winston-Salem facilities.

Qualifications

• Investigations and root cause analysis from customer complaints, CAPAs and trending.
• Interfaces with customers to provide reports, data and technical support for products and notifications.
• Performs and supports CAPA activities, including documenting, tracking and reporting.

Responsibilities

• Conduct investigations and root-cause analyses from customer complaints, CAPAs, and non-conformances.
• Interface with customers to provide data and technical support for products, complaints, and change control.
• Develop and monitor protocols for product evaluation and test method validations.
• Assist with supplier quality audits and supplier corrective actions (SCARs).
• Coordinate external audits and technical visits as requested.
• Lead continuous improvement activities (5S, Kaizen) and ensure regulatory compliance.

Job description

Charter Medical is seeking a Quality Engineer to support the Quality Management System in alignment with FDA 21 CFR Parts 210, 211 and 820 and ISO 13485:2016. The role focuses on customer complaints, CAPAs, audits, and continuous improvement to ensure product quality and regulatory compliance.

The position is 1st shift, Monday–Friday, with opportunities to lead CAPA activities and coordinate external audits across two Winston-Salem facilities.