Quality Engineer

Charter Medical•Winston-Salem, NC

26d•Onsite

About The Position

The Quality Engineer supports activities related to the successful overall performance of the company’s Quality Management System in support of FDA 21 CFR Parts 210, 211 and 820 and ISO 13485:2016. The incumbent will assist with Customer Complaints, Corrective and Preventative Actions (CAPAs), and Audits.

Requirements

Conducts investigations and Root Cause Analysis derived from Customer Complaints, CAPAs, Trending, Out of Specifications, Nonconformances, etc.
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 but not limited to, administrative duties for database maintenance, serve as CAPA team member or CAPA team leader, facilitate root cause analysis with CAPA teams, ensure CAPA documentation is complete and accurate, perform follow-up evaluation of CAPA effectiveness, and provide trending reports.
Addresses Customer Complaints, derived investigations, corrective actions implementation, and reporting.
Assists with hosting, preparing and coordinating external audits and/or Technical Visits as requested.
Coordinates, implements, and leads activities related to continuous process improvement of the Organization and the Quality System (5S, Kaizen, etc.)
Assists with ensuring raw materials in process products and finished goods inspected by complaints, CAPA or recall are segregated and dispositioned as necessary.
Analyzes non-conforming data, including complaint data, for trends and makes recommendations for corrective actions accordingly.
Accurately and thoroughly responds to customer requests for quality data or quality inquiries.
Assists with responses to external audits.
Conducts employee training as required (i.e., GMP, Root Cause Analysis and best practices).
Supports company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable FDA, ISO, EU and other regulatory requirements.

Responsibilities

Conducts investigations and Root Cause Analysis derived from Customer Complaints, CAPAs, Trending, Out of Specifications, Nonconformances, etc.
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 but not limited to, administrative duties for database maintenance, serve as CAPA team member or CAPA team leader, facilitate root cause analysis with CAPA teams, ensure CAPA documentation is complete and accurate, perform follow-up evaluation of CAPA effectiveness, and provide trending reports.
Addresses Customer Complaints, derived investigations, corrective actions implementation, and reporting.
Assists with hosting, preparing and coordinating external audits and/or Technical Visits as requested.
Coordinates, implements, and leads activities related to continuous process improvement of the Organization and the Quality System (5S, Kaizen, etc.)
Assists with ensuring raw materials in process products and finished goods inspected by complaints, CAPA or recall are segregated and dispositioned as necessary.
Analyzes non-conforming data, including complaint data, for trends and makes recommendations for corrective actions accordingly.
Accurately and thoroughly responds to customer requests for quality data or quality inquiries.
Assists with responses to external audits.
Conducts employee training as required (i.e., GMP, Root Cause Analysis and best practices).
Supports company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable FDA, ISO, EU and other regulatory requirements.
Acts as a Quality ambassador for the company to promote Quality culture.