CAPA Officer
We usually respond within two weeks
Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.
The CAPA Officer is responsible for managing the Corrective and Preventive Action (CAPA) process to ensure timely resolution of quality issues and systemic improvements. This role is critical in driving root cause analysis, risk assessment, and effectiveness verification to prevent recurrence and enhance product and process quality.
What you will do
- CAPA Management:
- manage CAPA records in the quality system,
- ensure CAPA records are completed within defined timelines,
- maintain CAPA documentation in compliance with internal and regulatory requirements. - Root Cause Analysis:
- facilitate and lead root cause investigations for quality events,
- applyCAPA tools,
- document investigation results and rationale for chosen corrective actions. - Risk Assessment:
- evaluate the risk associated with identified quality issues,
- prioritize CAPA activities,
- update risk management files if required. - Effectiveness Verification:
- develop effectiveness check plans to verify CAPA success,
- close CAPAs only upon successful verification of results.
What you bring
Experience
- Minimum 3 years of experience in Quality Assurance or Quality Systems in a regulated industry.
- Experience with nonconformance handling, complaint investigations, and audit findings.
- Familiarity with regulatory expectations for CAPA (FDA, ISO 13485, EU MDR).
Personal competencies
- Excellent analytical and communication skills, with ability to collaborate across departments.
- Experience with nonconformance handling, complaint investigations, and audit findings.
Who we are
At WSA, we provide innovative hearing aids and hearing health services.
Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.
With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.
Sounds wonderful? We can't wait to hear from you.
WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.
- Department
- Quality
- Role
- Group Quality - Quality Management System
- Locations
- Komorniki, Poland
Komorniki, Poland
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