Head of Global NC & MRB process

WSA – Wonderful Sound for All; Komorniki; On-site; PLN 260,000 - 340,000; Full time

Job summary

WSA – Wonderful Sound for All is seeking a Head of Business Quality to own global NC and MRB processes across regions and sites. You will establish governance, track performance metrics, and ensure compliance with ISO 13485, EU MDR, and FDA standards while driving continuous improvement.

In this senior role, you will lead cross-functional teams, escalate critical quality events, and partner with Regulatory, Operations, and Supply Chain to reduce risk and strengthen the quality system worldwide.

Qualifications

• 8+ years of experience in Quality Engineering/Quality Operations in regulated medical devices.
• Bachelor degree in Engineering or related natural science; Master’s preferred.
• Expertise in Non-Conformance management, deviation investigations, CAPA, and quality event escalation.
• Proven background governing global quality processes and cross-functional alignment.
• Experience with regulatory bodies and audits per ISO 13485, EU MDR, and FDA requirements.
• Strong leadership, influencing without authority, and managing escalations.

Responsibilities

• Ensure that all non-conformances are identified, investigated, escalated, and resolved per QMS and regs.
• Serve as central authority for NC management and MRB decision-making across regions and sites.
• Act as primary escalation point for significant non-conformances and complex MRB decisions.

Skills

Quality Engineering

Quality Operations

Regulatory Compliance

CAPA & Non-Conformance

Root Cause Analysis

Leadership

Stakeholder Management

Education

Bachelor's degree in Engineering or related science

Master's degree preferred

Job description

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 Head of Business Quality is the global NC and MRB Process Owner, accountable for the end-to-end governance, compliance, effectiveness, and continuous improvement of the Non-Conformance (NC) and Material Review Board (MRB) processes across all regions, manufacturing sites, and business functions.

What you will do

• The role ensures that all product, process, supplier, and system non-conformances are consistently identified, documented, investigated, assessed, escalated, and resolved in accordance with internal Quality Management System requirements and applicable regulatory standards, including ISO 13485, EU MDR, FDA 21 CFR Part 820, and other relevant global regulations. As the global NC and MRB Process Owner, the position establishes process standards, governance frameworks, performance metrics, and escalation pathways to ensure consistent execution and compliance across the organization.
• The role serves as the central Business Quality authority for NC management and MRB decision-making, ensuring appropriate containment, investigation, risk assessment, and product disposition of non-conforming materials. Through oversight of process performance and quality trends, the position drives harmonization, identifies systemic issues, and implements sustainable improvements to reduce recurrence and strengthen quality system effectiveness.
• The Head of Business Quality acts as the primary escalation point for significant non-conformances, critical quality events, and complex MRB decisions, facilitating risk-based decision-making and alignment across Operations, Quality, Regulatory Affairs, Supply Chain, and other key stakeholders.

What you bring

Experience

• 8+ years of experience in Quality Engineering, Quality Operations within regulated medical device or related industries.
• Bachelor degree in Engineering or other related natural science discipline combined with relevant experience.
• Master's degree is preferred.
• Demonstrated expertise in Non-Conformance management, deviation investigations, root cause analysis, corrective and preventive actions (CAPA), and quality event escalation.
• Proven background in governing global quality processes and driving cross-functional alignment across complex organizational environments.
• Experience interacting with regulatory bodies and supporting audits/inspections in compliance with ISO 13485, EU MDR, and FDA requirements.
• Strong leadership experience, including influencing without authority, managing high-stakes escalations, and driving strategic quality improvements across regions.

Personal competencies

• Strategic mindset with strong leadership and decision-making capabilities.
• Strong communication and stakeholder management skills, with the ability to influence across functions.
• Ability to operate effectively in a fast-paced, global environment with evolving priorities.
• Committed to quality excellence, compliance, and continuous improvement.

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.