Hands-On Quality Engineer for Medical Devices

Arch-Medical-Solutions; North Manchester (IN); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

ARCH Medical Solutions in Indiana seeks a hands-on Quality Engineer to build quality into manufacturing. You’ll work across production, customers, and suppliers to ensure processes, equipment, and test methods meet requirements and are validated.

You’ll investigate quality issues, develop corrective actions, perform root-cause analysis, and support PFMEAs, process capability studies, and inspections from receiving through final release.

Qualifications

• Bachelor’s degree or equivalent experience in a related field.
• Minimum 3 years of quality engineering in manufacturing.
• Knowledge of FDA QSR and ISO 13485 is preferred.
• Ability to read drawings and GD&T; strong analytical skills.

Responsabilités

• Serve as a technical resource for quality across manufacturing operations.
• Respond to customer quality questions, investigate issues, and implement solutions.
• Partner with production teams to provide training and technical support.
• Support validation of processes, equipment, and test methods.
• Evaluate risks and help establish PFMEAs.
• Participate in contract reviews to assess quality requirements.
• Ensure Device Master Records reflect customer needs and drawings.
• Contribute to quality control plans and inspection activities.
• Conduct or support process capability studies and MSAs.
• Develop inspection methods and frequency plans.
• Participate in internal and supplier audits.
• Investigate quality issues using RCA and support CAPA.
• Support receiving, in-process, and final inspections.
• Operate within ARCH Medical Grinding Quality Management System.

Connaissances

Quality engineering

Data analysis

Root cause analysis

Documentation

Communication

Formation

Bachelor's degree in a related discipline

Outils

CMM

Microsoft Office

Description du poste

ARCH Medical Solutions in Indiana seeks a hands-on Quality Engineer to build quality into manufacturing. You’ll work across production, customers, and suppliers to ensure processes, equipment, and test methods meet requirements and are validated.

You’ll investigate quality issues, develop corrective actions, perform root-cause analysis, and support PFMEAs, process capability studies, and inspections from receiving through final release.