Quality Engineer - Life Sciences QA & Regulatory

Corning; Durham (AR); Presencial; USD 67.000 - 92.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonuses & incentives

401(k) matching

Health benefits

Paid time off

EAP

Life insurance

Disability insurance

Parental leave

Descripción de la vacante

Corning is seeking a Quality Engineer to provide support for internal and external customers on quality and regulatory inquiries, and to act as a liaison with other Corning functions. The role covers projects and processes tied to the CMO, including investigations, CAPAs, and change controls.

You will collaborate with Quality, Regulatory, Sales, and Operations to ensure timely delivery of project deliverables, participate in customer audits, and help strengthen the QMS and process efficiency

Formación

• Bachelors in Engineering, life sciences, or related field.
• 2-4 years related experience in life sciences or manufacturing industry.
• Customer facing interactions to address concerns and resolve issues.
• Demonstrated knowledge of quality and regulatory practices strongly encourage.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.

Responsabilidades

• Performs investigations, implements corrective actions and ensures proper disposition of items as they relate to customer complaints.
• Provides responses and manages communications with customers for complaints and inquiries, identifying and escalating urgent quality and regulatory issues as needed according to the established policies and guidelines.
• Prioritizes key customers and urgent inquiries to the correct department as needed on demand according to QRS guidelines
• Communicates with contract manufacturing organizations to ensure resolution of any product concern.
• Work with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfaction and completion of any project deliverable in a timely manner.
• Participate in customer audits, working with customers and Plant Quality management to provide requested documentation within audit scope. Assure that all necessary components and agreements are in place prior to customer audit.
• Issues supplier corrective actions (SCARs), manages CAPAs and Nonconformance reports to ensure proper resolution of issues, implementation of corrective actions and effectiveness of such corrective actions.
• Creates change controls related to projects and changes necessary to maintain and support compliance of the QMS.
• Supports the sterilization assurance program for CMO products as deemed necessary.
• Help implement changes that improve compliance to the quality management system (QMS), supply flexibility, and process efficiency.
• Escalates any issues or concerns appropriately to ensure actions are taken that are commensurate with the risk.

Conocimientos

Customer interactions

Communication skills

Cross-functional teamwork

Time management

Regulatory knowledge

Quality systems

Attention to detail

Quality standards

Medical device experience

Data analysis tools

Educación

Bachelors in Engineering, life sciences, or related field

Herramientas

MS Office

Data analysis tools

Descripción del empleo

Corning is seeking a Quality Engineer to provide support for internal and external customers on quality and regulatory inquiries, and to act as a liaison with other Corning functions. The role covers projects and processes tied to the CMO, including investigations, CAPAs, and change controls.

You will collaborate with Quality, Regulatory, Sales, and Operations to ensure timely delivery of project deliverables, participate in customer audits, and help strengthen the QMS and process efficiency