We are excited to be working with one of our high growth clients as they look to appoint a Senior Quality Assurance Specialist covering Belgium and Luxembourg.
Our client is an international, entrepreneurial, family owned wound and skin care group headquartered in Luxembourg with local subsidiaries in Belgium, the Netherlands, Germany and the UK and a network of distributors in other countries. 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.
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.
Belgium & Luxembourg
Although this person has no direct reports for the moment, we want to hire someone with the capabilities to step into a managerial function over a certain period of time as the business to continues to grow!
* 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 department concerning submissions, design dossiers, technical files, clinical trials applications and other regulatory documents.
Package and Benefits
* 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 > 85k Salary
Key Skills, Qualifications and Client Requirements
* 3+ Years in quality assurance ideally in the pharmaceutical, medical, FMCG or OTC markets.
* 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's 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 lone working
* Strong interpersonal skills
* Problem solving ability
* Strong analytical ability
What Happens Next?
If you are interested in finding out more about this role, please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest. All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent. Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at email@example.com or call our Medical Devices team on 01423 813456,
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