Quality Engineer

Polyzen, Inc.; North Carolina; Presencial; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Root Cause Analysis

CAPA

Audits

Customer Complaints

SOPs

Descripción del empleo

Charter - Winston-Salem
Winston-Salem, NC 27103, USA

• On-site
• Charter - Quality Assurance
• Full-Time
• Requisition #: QUALI002620

Description

Who we are:

Charter Medical, part of the Solesis family of companies, specializes in single-use solutions that enable life sciences innovators to turn bold ideas into lasting breakthroughs, supporting industry-leading companies in bringing life-saving therapies to market. Operating in North Carolina, Charter Medical employs more than 150 team members across two facilities in Winston-Salem.

Guided by a commitment to quality, innovation and customer success, Charter partners with customers to transform promising therapies into commercial realities. Employees contribute to solutions that support life-changing treatments and make a meaningful impact on patients around the world.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

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.

What you will do:

• 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.

Who you are:

• 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.
• Generous Paid Time Off
• Annual Bonus
• 401(k) with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.