We recruit for one of our clients, an international family owned company with ambitious growth plans in the pharmaceutical and medical device technological domain, a QA Senior Specialist in Medical Devices.
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 the company’s 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.
Your profile
- Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience
- A minimum of 2 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
This position is a permanent contract for a company based in Esch/Alzette.
Interested?
If you identify yourself with the requirements of this challenging position, do not hesitate to apply by clicking on the button below.
Applications sent through the dedicated form on MySpringProfessional will be priorily processed.
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