Quality Assurance Specialist

Come and join a large MedTech manufacturer that is well‑known all around the world and has a brand that precedes it. This is a well‑established company with a team that feels like a small family with its own culture and community; you will not be just another number in the employee count here. A continuous investment into developing new products and a mission to create new value is what makes their products state‑of‑the‑art, innovative medical devices. You will not only lead the harmonisation of the company’s Quality Management System but also become the go‑to person for any Quality questions from the business.

Opportunity

As a Quality System Specialist you will shape, mould and harmonise the existing Quality Management System, not just fine‑tune and perform maintenance activities like in other companies. As a Quality System Specialist, you will gain extensive and valuable knowledge in quality within a short space of time and be able to demonstrate how you have shifted the needle for a global player such as this one.

• Manage review meetings and other processes related to Non‑conformances, CAPAs, Customer Complaints, Deviations as needed
• Be responsible for owning and managing the Quality System documents and records
• Support and take part in notified body audits as well as conducting internal audits
• Lead supplier audits and reviews to analyse their performance according to business timelines
• Be a go‑to person to answer any Quality and Regulatory Affairs questions from internal and external partners
• Work cross‑collaboratively with the regulatory department to assist in day‑to‑day Regulatory Affairs activities
• Approximately 25% travel to the various sites throughout Europe
• 3+ years of experience in quality systems for medical devices
• ISO13485
• ISO27001
• Experienced working in small/medium sized companies

Equal Opportunity Employer

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.