Responsible for developing and maintaining a certified QMS according the applicable requirements (ISO 13485) for Spanish Subsidiary embedding all global processes into local QMS, and contribute to improve quality of products and processes
- Control and further development of the QMS (Quality Management System).
- Planning, monitoring and execution QMS activities.
- Coordinate and execute the deployment of global processes.
- Coordinate the creation, monitoring and control of QM (Quality Management) documents and records.
- Planning, initiating coordination and evaluation of internal QM projects and cross-functional working groups.
- Collecting and evaluating information and data as part of quality monitoring.
- Planning and execution of all internal audits.
- Preparation and follow-up and monitoring of external audits.
- Contribute to the development of quality policies and objectives. Development of corresponding process descriptions, guidelines and specifications.
- Planning and implementation of training on the QMS.
- Motivation and advice of employees regarding QMS.
- QM training of new employees during induction.
- Definition of type and scope of quality checks.
- Control of the operational capability of all measuring devices (functionality, calibration, etc.).
- Maintain the risk management system.
- Support site continuous improvement initiatives.
Experience and Qualifications
- Graduate degree/studies at the University.
- A minimum of 2 years of experience in positions of increasing responsibility of taking care of quality management system of operational site in global organizations.
- Fluent working in English.
- Proficient user of MS Office, Excel, Word, PowerPoint.
- Residence in Alicante.
- QMS Auditor Certification.
- Having worked in a Lean/Six Sigma environment is an asset.
- Graduate degree/studies in engineering, Electronics, Software and/or Mechanical Engineering or quality.
- Experience in Medical Device industry.
- Knowledge of ISO 13485.
- Quality Management system software, SAP R/3, MS Project are an asset.
- Strong Ability to work independently and in a team environment.
- Flexible with priorities and responsibilities.
- Analytical and conceptual thinking.
- Works well under pressure in a dynamic timeline-driven environment.
- Strong organization skills.
- Results-oriented and decisive.
- Having the ability to work from strategic to hands on activities.
- Strong negotiation skills.
- Can drive continuous process improvements.
- Ability to set priorities.
- Exceptional written and verbal communication skills.
We offer you an international environment, the opportunity to work for an innovative company with a good reputation known for its expertise and the know-how to develop high quality products, a job with a lot of responsibility where you can count on the cooperation and the full support of the management.
If you are interested in applying for this position, please submit your CV and cover letter in English.
We guarantee confidentiality.