Quality Assurance Specialist - ISO & CAPA

RR Donnelley; Plover (IA); Presencial; USD 64.000 - 98.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision

401(k) with company match

Paid time off

Parental leave

Tuition assistance

Employee discounts

Descripción de la vacante

RR Donnelley in Plover, WI is seeking an experienced Quality Specialist to ensure conformance to internal and external quality standards, and to assist customers, sales teams, suppliers and division staff.

You’ll help establish quality standards, lead CAPA activities, participate in ISO programs and continually improve processes to reduce defects across manufacturing.

The role offers a competitive salary range of $64,000–$98,400 per year, plus benefits and opportunities for career growth.

Formación

• Bachelor degree in discipline related to functional work is strongly preferred but not required.
• Experience working in an FDA regulated environment is preferred.
• Knowledge of CAPA processes and their role in quality management.
• Familiarity with a Quality Management System (QMS).
• Must be able to recognize anomalies and critical situations and respond appropriately.
• Must be able to communicate with a variety of internal/external customers and/or co-workers to resolve issues of moderate complexity.
• Proficient with Microsoft Office; Google Suite knowledge strongly preferred.

Responsabilidades

• Assists in establishing, promoting and coordinating lines of communication between the customer, sales representatives, suppliers and division personnel.
• Interacts with customers, suppliers, vendors and division personnel regarding quality and production issues. Attends job production pre-planning meetings.
• Evaluates input material on a job and guides the customers to deliver material that will produce a high quality job.
• Performs press color approvals for both internal and external jobs.
• Assists in developing procedures and techniques for reducing process variation and manufacturing delays.
• Assists manufacturing personnel in establishing standards of quality and certifying that standards have been met.
• Communicates with sales, customer service and the customer to resolve quality issues.
• Negotiates resolution of customer or manufacturing complaints.
• Assists in creating and maintaining the statistical process control program.
• May be responsible for ISO programs within the division including audits and training.

Conocimientos

Strong communication

CAPA processes

QMS knowledge

Detail oriented

Problem solving

FDA regulated environment

Microsoft Office

Google Suite

Educación

Bachelor's degree in related discipline

Herramientas

Microsoft Office

Google Suite

Descripción del empleo

RR Donnelley in Plover, WI is seeking an experienced Quality Specialist to ensure conformance to internal and external quality standards, and to assist customers, sales teams, suppliers and division staff.

You’ll help establish quality standards, lead CAPA activities, participate in ISO programs and continually improve processes to reduce defects across manufacturing.

The role offers a competitive salary range of $64,000–$98,400 per year, plus benefits and opportunities for career growth.