CAPA & Quality Improvement Specialist

WSA EMEA; Polska; On-site; PLN 80,000 - 100,000; Full time

Job summary

A leading medical technology company is seeking a CAPA Specialist to support the Corrective and Preventive Action process. This role involves conducting root-cause analysis and risk assessments to resolve quality issues and improve overall product quality. The ideal candidate has a minimum of 3 years in Quality Assurance within a regulated industry, experience with nonconformance handling, and familiarity with CAPA regulations. Join us to make a meaningful impact in people's lives through innovative hearing health solutions.

Qualifications

• Minimum 3 years of experience in Quality Assurance or Quality Systems in a regulated industry.
• Experience with nonconformance handling and complaint investigations.
• Familiarity with regulatory expectations for CAPA (FDA, ISO 13485, EU MDR).

Responsibilities

• Support the CAPA process to resolve quality issues and drive improvements.
• Conduct root-cause analysis and perform risk assessments.
• Verify the effectiveness of actions to prevent recurrence.

Skills

Analytical skills

Communication skills

Risk assessment

Root cause analysis

Job description

A leading medical technology company is seeking a CAPA Specialist to support the Corrective and Preventive Action process. This role involves conducting root-cause analysis and risk assessments to resolve quality issues and improve overall product quality. The ideal candidate has a minimum of 3 years in Quality Assurance within a regulated industry, experience with nonconformance handling, and familiarity with CAPA regulations. Join us to make a meaningful impact in people's lives through innovative hearing health solutions.