Quality Assurance Manager, Elos Medtech

A great opportunity for you who are ambitious - and enjoys playing a key role focusing on quality and environmental activities!

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Elos Medtech, is looking for an experienced Quality Assurance Manager to take overall responsibility for quality and environmental activities at our Gørløse site, a key part of Elos Medtech’s global dental operations.

In this role, you’ll work closely with site leadership and global QA teams to maintain high compliance standards, drive continuous improvement, and foster a culture of quality across all departments. You’ll be a core member of both the Site Management Team and Global QM/QA Steering Group.

Key areas of responsibility
As our new Quality Assurance Manager, you will lead and develop the local QA team of nine experienced engineers, fostering a culture of quality and continuous improvement. Your key responsibilities can be described as follows:

Maintain and evolve the site’s Quality and Environmental Management System to meet ISO 9001, ISO 13485, ISO 14001, and MDSAP requirements.
Ensure regulatory compliance with standards such as FDA and MDR, including audit readiness and CAPA management.
Act as the Management Representative for the Gørløse site and a key QA contact for external audits and inspections.
Represent QA in the Site Management Group, ensuring alignment on daily operations and strategic priorities.
Prepare and deliver quality performance reports to site leadership and global QA leadership.
Oversee all quality-related documentation and lead the execution of the annual “Target Breakdown.”
Manage internal and external audits, ensuring timely implementation of corrective actions.
Maintain budget responsibility for QA and environmental functions.
Collaborate cross-functionally with production, engineering, and supply chain to embed quality into every process.
Participate in global QA initiatives and contribute to harmonization efforts across Elos Medtech sites.

You will refer to Adrian Hofer, VP Global QM/QA, who is based at Elos Medtech, Switzerland. You should be prepared for some travel activity - estimated to 10-20 days a year.

About You
We are looking for someone who thrive in a global, decentralized and growth-oriented value driven environment with high ethical standards and a strong culture. You can recognize your self in the following description:

Minimum 5+ years of leadership experience in quality assurance within medical devices or another regulated manufacturing environment.
Degree in engineering, life sciences, or a comparable technical field.
Expertise in ISO 9001, ISO 13485, ISO 14001, and MDSAP standards.
Practical experience with regulatory frameworks such as FDA and MDR.
Strong understanding of QMS implementation, audit leadership, and CAPA processes.
Fluent in English; proficiency in Danish or another European language is an advantage.

As a person and leader, you are a self-starter with excellent communication and leadership skills with the ability to build trust across all levels. You have a strategic and hands-on approach to quality management with strong execution skills. Finally, you are open and positive – and perhaps ready for an international career.

Working at Elos Medtech
Elos Medtech is a workplace for committed and passionate people who are looking for innovation, growth and opportunities, something we also offer our customers. Our employees are proud of the knowledge and expertise that has developed within the company over the years. We offer a workplace based on cooperation, solidarity, and reliability. We believe in giving our employees opportunities to develop in their work and influence their future.

Any questions?
Please contact consultant Knud Mansfeld-Giese, Alumni who is handling this assignment on behalf of Elos Medtech.

Elos Medtech is one of the leading development and production partners for medical devices and components in the world, specializing in dental and orthopedic implants and instruments. Working predominantly as a contract manufacturer the company strives to serve customers as early as possible in the development phase.

Elos Medtech has today more than 1500 employees with a turnover of approximately 250 MEUR. Operations are conducted at 13 facilities in six countries located globally, including Europe, the US and China. The business is organized in five Business units Ortho, Dental, Spine and Procedure Kits, Precision and Life Science. Elos Medtehc is owned by TA Associates, a leading global growth private equity.

For more information about Elos Medtech please visit them here.

Please email us your application and attach your CV by clicking on the apply button below.

Apply