Senior Expert, Process Validation and Project Management

At WSA, we combine deep audiological insight with advanced engineering to create hearing solutions that truly make a difference. Our work bridges science and technology—translating complex challenges into meaningful user experiences that improve people’s lives.

As part of our Operations and Business Quality organization, you will play a key role in ensuring that our manufacturing processes and equipment consistently meet the highest standards of quality, safety, and regulatory compliance (ISO 13485, FDA, MDR). If you are motivated by validation excellence, structured problem-solving, and building robust and compliant production processes in a highly regulated environment, this role offers both purpose and impact.

The Team

You will be part of the Lynge Operations organization, working closely with Manufacturing, QA, NPI, Engineering, and global operations teams. While the role has a local scope, you will collaborate internationally with colleagues in other locations sharing best practices and ensuring alignment across sites.

The position reports to Senior Manager, Manufacturing Technology Development and does not include people management responsibility. Instead, you will act as a local validation subject matter expert, driving validation projects and handling non-conformance in production processes across the local site.

What you will do

As Senior Validation Expert, you will take end-to-end responsibility for validation of production equipment and processes, ensuring a robust, efficient, and regulatory-compliant manufacturing environment. Your key responsibilities will include:

• Act as a project manager in implementing larger validation projects with stakeholders and participating in many professional groups.

• Acting as the validation expert, providing guidance and support across manufacturing operations with full accountability for validation activities, including planning, execution, oversight, and compliance.

• Planning, executing, and documenting process and equipment validation activities including master validation plans and IQ/OQ/PQ

• Ensuring that machinery and processes are under appropriate statistical process control, with identified and controlled Critical Process Parameters

• Performing and maintaining risk-based validation activities, including (P)FMEA

• Supporting compliance with applicable medical device regulations and the company Quality Management System

• Establishing and supporting continued process verification and process monitoring

• Contributing to production stabilization, troubleshooting, and continuous improvement initiatives

• Supporting and participating in projects, including the implementation of new equipment, technologies, and production processes

• As this - position requires collaboration with our colleagues around the world, 1-2 business trips per year is to be expected (5-10 days)

What you bring

We imagine that you hold a degree in Engineering (e.g. Mechanical, Manufacturing, Automation, or similar) and bring extensive experience from validation and regulated manufacturing environments such as the medical device or pharmaceutical industry.

Experience

• Minimum 5 years of experience within validation, quality, or manufacturing, ideally in the medical device industry

• Proven experience managing validation projects end-to-end

• Strong knowledge of process validation, IQ/OQ/PQ, CPV, and risk-based validation

• Solid understanding of FDA regulations and medical device compliance requirements

• Experience working cross-functionally in complex production environments both locally and globally

• Project management experience is considered an advantage

Language Skills

• Fluency in Danish and English, both written and spoken

Personal competencies

• Highly detail-oriented with a strong quality and compliance mindset

• Strong stakeholder management and collaboration skills across functions and sites

• Structured, analytical, and systematic in your approach to complex problems

• Comfortable working independently while influencing without formal authority

• Proactive, solution-oriented, and motivated by 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 whe