Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has 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 are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.
We are looking for an experienced hands-on quality specialist to support the daily operational performance of the quality department, ensure the successful delivery of quality objectives, whilst adhering to regulatory compliance and achieving commercial success. This full-time but temporary assignment for 6 months position for an immediate start will be located in our Belgium office (Kontich), Luxemburg offices (Esch-sur-Alzette) with the possibility to work from home occasionally.
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospects
- Learning and development opportunities
- Competitive remuneration according to experience
- Maintain and adjust the electronic Quality Management System, alongside its current ongoing implementation. Identify problems and provide solutions for resolution. Determine system improvements for both compliance to ISO 13485 & 21CFR 820 and overall performance.
- Setup of the procedures, instructions, and trainings for implementation of the different QMS modules and provide training to key users.
- Handling of complaints and deviations (internal and external), including root cause analysis and subsequent CAPA handling.
- Prepare and complete quality documentation and reports regarding quality, and customer-requirements by collecting, analyzing, and summarizing information and trends including failed processes, recalls, complaints and CAPAs.
- Participate in risk management, both product and business oriented.
- Participate in the Change control process, both Quality and other.
- Assist in quality audits: audits from authorities and companies, internal audits, external audits with Flen Health customers and inspections. Performs external audits at suppliers/subcontractor.
- Promote quality awareness throughout the company. Train all staff concerning the Quality Management System and the use of Quality Management System.
- Stimulate other departments to optimize processes and documents and help where possible.
- Assist in implementing quality strategies including global strategies that ensure procedures and policies meet applicable standards and regulations.
- 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 Regulatory and R&D departments to ensure QMS alignment concerning submissions, design dossiers, technical files and other regulatory and R&D documents.
You will maintain and further improve the Quality Management System, including internal and external audits, and monitor the implementation of the e-QMS to comply with the ISO13485:2016, 21CFR 820 and regulatory requirements for Medical Devices in order to maintain the necessary quality certification. You will set up quality improvement programs to increase overall quality performance.
Your qualifications & experience:
- A minimum of 5 years successful working experience in a quality department
- Knowledge/Experience of quality processes and procedures
- Knowledge of applicable GxP ; 21 CFR 820 and ISO 13485
- Fluency in English; both written and spoken
- Analytical thinking & problem-solving capability
- Hands-on – Initiative taking
- QMS Software experience
- ISO/EN auditor certificate or with the desire to obtain it
- Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience
- Excellent planning and organizational skills
- Strong communication skills both written and verbal
- Self-motivated team worker who is equally capable of working independently
- Strong interpersonal skills
- Problem solving ability
- Strong analytical ability
Are you interested in working with an ambitious and highly dedicated team?
Please send your CV and covering letter by using the form below: