Our client, based in the south of Luxembourg, is a company in the medical field. To strengthen its team, this firm is looking for a Senior Quality Specialist for a position in Luxembourg, Belgium or the United Kingdom.
Your responsibilities :
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.
Your profile and qualifications :
You have a minimum of 5 years successful working experience in a quality department in the scientific field
You are fluent in English. Any other language is an asset.
You have Knowledge of applicable GxP ; 21 CFR 820 and ISO 13485
Excellent written communication skills
You are a motivated, hard-working and autonomous person
You are open-minded and solution-oriented.
Conditions and Advantages :
Immediate start of work
Pleasant working environment
Young and dynamic team
The candidates' career path :
Analysis of your application
Pre-interview with RH Lab (by phone)
Interview at RH Lab.
2 interviews with our client
Applications sent directly to RH Lab.'s clients are systematically forwarded to us and result in additional processing time.