Quality Specialist (M/W/D)

BE, DE, LU, or NL - Fulltime 

Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device markets. We have a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.

At Flen Health, we focus on people with topical inflammatory and infectious diseases. Our vision is to shape a world, where wounds and skin disorders do not stop patients from living the life they love by developing innovative technologies and distributing them across the globe.

At Flen Health, we expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working ecosystem, enthusiastic colleagues, and an attractive remuneration package.

We are looking for a Quality Specialist for an immediate start to reinforce the Quality department and this role will report directly to the Quality Director. This is a permanent full-time position that can be based in one of our subsidiaries: Belgium, Luxembourg, the Netherlands, or Germany.

As a Quality Specialist, you will ensure the company meets its quality objectives by maintaining regulatory compliance and driving commercial success. This includes managing the quality management system, conducting audits, and ensuring adherence to ISO13485:2016 and regulatory requirements. Additionally, you will implement quality improvement programs to enhance overall performance.

This position will suit you perfectly if you have a taste for challenges and the desire to make things happen!

What we offer:

• Excellent working conditions
• An innovative and inspiring international work environment
• Independent project work & responsibilities within a professional team
• Career prospects
• Learning and development opportunities
• Competitive remuneration according to experience 

Your responsibilities:

QMS software:

• Maintain and adjust the electronic Quality Management System to support the organization with pragmatic and compliant processes

• Identify problems and provide solutions for resolution

• Determine system improvements for both compliance with applicable standards and regulations and overall performance

QMS processes:

• Supporting all departments by setting up their written procedures, instructions, and trainings

• Handling QMS-related deviations, monitoring status and timeliness, assisting others and executing independent root cause analysis and subsequent elimination of cause actions

• Liaison with external parties on matters relating to the Quality Management System

• Own the QMS process risk management

• Own the QMS change control process, including monitoring, and executing. Supporting others

Data analysis:

• Prepare, organize, and moderate Quality Review and Management review reports

• Collect, analyze, and summarize data of e.g. Deviations, internal/external QMS Audits

• Identify risks and trends, define, and execute corrective and preventive actions

Audits:

• Perform internal and supplier audits to guarantee their contribution to the compliance of the Flen Health products, services and QMS

• Organize, participate and be the contact person for Notified Body in 3rd party Audits

• Manage and monitor the internal audit program

Communication, Awareness and Training:

• Promote quality awareness throughout the company

• Train internal and external on Quality Management System and the use of the Quality Management System where required

• Stimulate other departments to optimize processes and documents and help where possible

• Provide input to develop and implement quality strategies including global strategies that ensure procedures and policies meet applicable standards and regulations

• Follow-up on market and quality trends related to the specialist's expertise

• Maintain proper communications with other departments to ensure communication and good relationships in connection with matters related to the quality management system

• Close cooperation with the Regulatory and R&D departments to ensure QMS alignment concerning submissions, design dossiers, technical files, applications and other documentation

Your qualifications & experience:

• You are graduated (Master’s degree) in Pharmaceutical Science or in Science or equivalent based on relevant experience

• You demonstrate at least 5 years of successful working experience in a medical device quality department

• You have experience with quality processes and procedures

• You possess strong experience with at least ISO 13485 and MDR (Medical Device Regulation)

• You have in-depth knowledge of other Regulatory applicable regulations in the medical device and/or pharma industry

• You have proven competence as an (internal) auditor

• You know good documentation practices and have some GxP experience

• You have analytical thinking & problem-solving capability

• You are proficient in MS Office

• You have QMS software knowledge

• You have good knowledge/experience in semi-solids manufacturing and Quality Control

• You are fluent in English, oral and written. Other languages such as Dutch, German or French are an asset

Are you interested in working with an ambitious and very dedicated team?

Please submit your application, CV, and motivation letter to the following email address: This email address is being protected from spambots. You need JavaScript enabled to view it.