Quality 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

Driven by the passion to improve the 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 Specialist is responsible for supporting a Corrective and Preventive Action (CAPA) process to ensure the timely resolution of quality issues and drive systemic improvements. This position focuses on conducting root‑cause analysis, performing risk assessments, and verifying the effectiveness of actions to prevent recurrence and strengthen overall product and process quality.

What you will do

CAPA Management:

• Continuously review Nonconformity (MC) and CAPA records in the quality system.
• Support the timely completion of NC and CAPA records.
• Support maintenance of NC and CAPA documentation in compliance with internal and regulatory requirements.

Root Cause Analysis:

• Assist in root cause investigations for quality events.
• Apply appropriate CAPA tools for assigned actions.
• Document investigation results and the rationale for selected corrective actions.

Risk Assessment:

• Support risk evaluations associated with identified quality issues.
• Prioritize CAPA activities to ensure timely and effective resolution. ప్రయత్న d
• Provide input to risk management files, as required.

Effectiveness Verification:

• Support the development and reinforcement of effectiveness check plans to confirm successful completion of CAPAs.
• Finalize CAPAs records upon successful verification of results.
• Support Corporate QMS activities, e.g. training in NC and CAPA processes, KPI and trend reporting, acting as an internal auditor, and preparing for and participating in internal/external audits.

What you bring

Experience

• Minimum 3 years of experience in Quality Assurance or Quality Systems in a regulated industry (preferably Med‑Tech industry)
• Experience with nonconformance handling, complaint investigations, audit findings and root cause analysis methods (e.g. 5Why, Fishbone)
• Familiarity with regulatory expectations for CAPA (FDA, ISO 13485, EU MDR)
• Auditor experience preferred.

Personal competencies

• Strong analytical and communication skills, with the ability to collaborate effectively across departments
• Capability to work independently while ensuring timely completion of assigned tasks including efficient documentation skills
  

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.