Quality Engineer II - CAPA & Process Validation

Teleflex Incorporated; Olive Branch (MS); On-site; USD 70,000 - 90,000; Full time

Job summary

Teleflex is seeking a Quality Engineer to support Quality and Operations, collaborating with cross-functional teams across engineering, quality and programs. You will lead CAPA/NC processing, investigations, and supplier quality activities while ensuring compliance with ISO 13485 and CFR 820.

Responsibilities include process validations, documentation control, and leading continuous improvement projects with a strong focus on product quality and customer satisfaction.

Qualifications

• 3+ years of Quality Assurance experience in medical device/FDA-regulated industry preferred.
• Knowledge of ISO 13485 and CFR 820.
• Experience with SAP applications desirable.

Responsibilities

• Lead NC/CAPA processing and investigations, and drive corrective actions.
• Serve as primary investigator for service complaints and CAPA champions.
• Guide protocol development, validation, and report reviews; ensure QMS compliance.
• Support FDA/ISO inspections and regulatory audits; maintain documentation control.

Skills

Quality Assurance

CAPA

Audit

Statistical analysis

Root cause analysis

Lean principles

Communication skills

Problem solving

Education

Bachelor's degree in Engineering

Tools

SAP

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Teleflex is seeking a Quality Engineer to support Quality and Operations, collaborating with cross-functional teams across engineering, quality and programs. You will lead CAPA/NC processing, investigations, and supplier quality activities while ensuring compliance with ISO 13485 and CFR 820.

Responsibilities include process validations, documentation control, and leading continuous improvement projects with a strong focus on product quality and customer satisfaction.