In order to ensure compliance with global regulations, our client, a well-known international company, asked us to identify and recruit a highly qualified, experienced and motivated Consultant for a project of minimum 6 months, starting ASAP.
The company is based in Luxembourg, remote working is culturally used.
- Build and implement a Quality Management System for Medical Device selection and ensure compliance with the Medical Device Regulation GMP, GDP and ISO 13485.
- Build and manage internal audit programs and report on findings.
- Revise, write, and author policies and procedures to maintain compliance to requirements.
- Manage the entire Quality Management System including change control, supplier qualifications, training, documentation management, quality agreements, CAPA, investigations, risk management, customer complaints, management review etc.
- Educate and train team members regarding their impact on quality.
- Establish and implement metrics to support process improvements and predict trends.
- Bachelor’s degree required with a scientific focus.
- 4+ years of experience in the medical device, medical device distribution or similar industry.
- Significant work experience in a fast-paced environment, ideally in product compliance with strong knowledge of GMP, GDP and ISO 13485.
- Strong verbal and written communication skills, excellent organizational skills, interpersonal skills and adaptability are essential
- Proficiency in English, any other European language would be considered as a plus
- Demonstrated experience creating sustainable processes with mechanisms used to ensure compliance with process.
- Immediately available
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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