Quality Engineer

Solesis•Winston-Salem, NC

25d

About The Position

The Quality Engineer supports the overall performance of Charter Medical’s Quality Management System in accordance with FDA 21 CFR Parts 210, 211 and 820 and ISO 13485:2016. The role assists with customer complaints, corrective and preventive actions (CAPAs), and audits, while supporting quality activities across products, processes, suppliers, and customer interactions. Charter Medical, part of the Solesis family of companies, specializes in single-use solutions for life sciences innovators. The company operates two facilities in Winston-Salem, North Carolina, and employs more than 150 team members. This is a first-shift role, Monday through Friday, from 8:00 a.m. to 5:00 p.m.

Responsibilities

Conduct investigations and root cause analyses related to customer complaints, CAPAs, trending, out-of-specifications, and nonconformances.
Interface with customers to provide reports, data, and technical support regarding products, complaints, change control, and customer notifications.
Develop and monitor implementation of protocols for product evaluation as required.
Create, edit, and revise test method validations, SOPs, work instructions, and product specifications as required.
Perform supplier quality audits and supplier corrective actions (SCARs), and issue notifications.
Support the corrective action system, including database maintenance, serving as a CAPA team member or leader, facilitating root cause analysis, ensuring CAPA documentation is complete and accurate, evaluating CAPA effectiveness, and providing trending reports.
Address customer complaints, including investigations, implementation of corrective actions, and reporting.
Assist with hosting, preparing, and coordinating external audits and technical visits.
Coordinate, implement, and lead continuous process improvement activities for the organization and Quality System, including 5S and Kaizen.
Assist in ensuring raw materials, in-process products, and finished goods subject to complaints, CAPAs, or recalls are segregated and dispositioned as necessary.
Analyze nonconforming data, including complaint data, for trends and recommend corrective actions.
Respond accurately and thoroughly to customer requests for quality data and quality inquiries.
Assist with responses to external audits.
Conduct employee training as required, including GMP, root cause analysis, and best practices.
Support company goals, policies, procedures, Good Manufacturing Practices, and applicable FDA, ISO, EU, and other regulatory requirements.
Act as a Quality ambassador and promote a quality culture.