Quality Engineer – QA, CAPA & Audits (Bonus + Benefits)

Polyzen, Inc.; Winston-Salem (NC); On-site; USD 75,000 - 110,000; 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 Disabled

Job summary

Charter Medical, part of the Solesis family, seeks a Quality Engineer to support the Quality Management System per FDA and ISO requirements. You will assist with customer complaints, CAPAs, audits, and continuous improvement initiatives at the Winston-Salem facility.

Responsibilities include conducting investigations, root cause analyses, coordinating with customers on reports, and developing protocols for product evaluation.

Qualifications

• Investigations and Root Cause Analysis derived from Customer Complaints, CAPAs, Trending, Out of Specifications, Nonconformances.

Responsibilities

• Conducts investigations and Root Cause Analysis derived from Customer Complaints, CAPAs, Trending, Out of Specifications, Nonconformances.
• Interfaces with customers to provide reports, data and/or technical support for Products, Complaints, Change Control and Customer Notifications.
• Develops and monitors implementation of Protocols for product evaluation as required.
• Creates, edits and/or revises Test Method Validations, SOPs, WIs, Product Specifications as required.
• Performs Supplier Quality Audits, SCARs (Supplier Corrective Actions) as well as Notifications issuance.
• Assists with Corrective Action system, including administrative duties for database maintenance, CAPA team involvement, trend reporting.
• Addresses Customer Complaints, derived investigations, corrective actions implementation, and reporting.
• Assists with hosting external audits and Technical Visits as requested.
• Coordinates, implements, and leads continuous process improvement of the Quality System (5S, Kaizen).
• Analyzes non-conforming data for trends and corrective actions recommendations.
• Responds to customer requests for quality data or inquiries.
• Supports FDA, ISO, EU regulatory requirements and company quality goals.
• Acts as a Quality ambassador for the company.

Skills

Root Cause Analysis

CAPA Management

Audits

Quality Documentation

Job description

Charter Medical, part of the Solesis family, seeks a Quality Engineer to support the Quality Management System per FDA and ISO requirements. You will assist with customer complaints, CAPAs, audits, and continuous improvement initiatives at the Winston-Salem facility.

Responsibilities include conducting investigations, root cause analyses, coordinating with customers on reports, and developing protocols for product evaluation.