Quality Engineer – GMP/ISO Focus with Impact & Benefits

Polyzen, Inc.; North Carolina; On-site; USD 65,000 - 90,000; 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 Disabi l

Job summary

Charter Medical, part of the Solesis family, is hiring a Quality Engineer to support the Quality Management System (FDA and ISO 13485). The role involves handling customer complaints, CAPAs, audits, and continuous improvement initiatives across two Winston-Salem facilities.

Responsibilities include root-cause analysis, reporting to customers, and coordinating external audits. Proficiency with GMP and regulatory requirements is essential; on-site work from Monday to Friday completes the role.

Qualifications

• Experience supporting FDA/ISO quality systems (21 CFR Parts 210,211,820; ISO 13485).
• Proven ability to investigate, identify root causes and implement CAPAs.
• Experience coordinating and hosting external audits and customer inspections.

Responsibilities

• Conduct investigations and root cause analysis from customer complaints, CAPAs, and nonconformances.
• Interface with customers to provide reports and technical support for quality issues.
• Develop and monitor protocols for product evaluation and test method validations.
• Create and revise SOPs, WIs, and product specifications as required.
• Perform supplier quality audits and supplier corrective actions (SCARs).
• Assist CAPA system administration and trending reporting; ensure CAPA documentation is complete.

Skills

Root Cause Analysis

CAPA

Audits

Customer Complaints

SOPs

Job description

Charter Medical, part of the Solesis family, is hiring a Quality Engineer to support the Quality Management System (FDA and ISO 13485). The role involves handling customer complaints, CAPAs, audits, and continuous improvement initiatives across two Winston-Salem facilities.

Responsibilities include root-cause analysis, reporting to customers, and coordinating external audits. Proficiency with GMP and regulatory requirements is essential; on-site work from Monday to Friday completes the role.