Senior Quality Engineer: CAPA & RCCA Leader in Med Devices

barrywehmiller; Flagstaff (AZ); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Machine Solutions is seeking a Senior Quality Engineer to partner with Manufacturing, Engineering, Supply Chain, and Operations to improve product quality and reduce risk. You will lead RCCA investigations and CAPA activities while supporting MRB and supplier-related processes.

The role requires a Bachelor's degree in a technical field and at least five years in manufacturing quality engineering, with experience in AS9100/ISO standards and regulatory expectations.

Formación

• Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical discipline.
• Minimum of five years of Quality Engineering experience in a manufacturing environment.
• Demonstrated experience leading RCCA investigations and managing nonconforming material.
• Experience facilitating CAPA reviews and managing supplier corrective actions.

Responsabilidades

• Lead RCCA investigations using 8D, 5-Why, Fishbone, and other structured methodologies.
• Facilitate and manage CAPA activities with timely implementation and verification.
• Support MRB activities, including disposition of nonconforming material.
• Manage supplier quality performance, supplier audits, and SCARs.
• Implement preventive actions to reduce defects, scrap, rework, and recurring quality issues.
• Support internal, customer, and third-party audits.
• Train, mentor, and develop team members.

Conocimientos

RCCA investigations

CAPA management

MRB support

Supplier quality

Internal audits

Team mentoring

Drawing interpretation

Educación

Engineering degree

Descripción del empleo

Machine Solutions is seeking a Senior Quality Engineer to partner with Manufacturing, Engineering, Supply Chain, and Operations to improve product quality and reduce risk. You will lead RCCA investigations and CAPA activities while supporting MRB and supplier-related processes.

The role requires a Bachelor's degree in a technical field and at least five years in manufacturing quality engineering, with experience in AS9100/ISO standards and regulatory expectations.