Quality System Specialist - Medical Devices
Great Growth Opportunity
Il nostro cliente
Biomedical Production Company
La figura ricercata
Reporting to the Quality Assurance Manager, the Quality System Specialist is accountable for the development, implementation and maintenance of Quality Management Systems in compliance with relevant quality system standards
- Lead, develop and execute the Quality System to ensure it is successfully maintained and improved when needed. Additionally, act as interface to all key stakeholders (suppliers, customers, Notified Body, Regulatory Authorities, etc)
- Lead, develop and execute the Documentation Control process. Ensure all QMS and product related documents and records all well-established, reviewed, approved, stored and implemented.
- Monitor Processes and Metrix including performance indicators to monitors and drives department progress against goals and objectives.
- Report on the performance of the quality system to executive management, lead management reviews and disseminate information through the organization
- Provide leadership and conduct quality audit activities when applicable including internal audits, supplier audits, customer audits and Notified body audits.
- Qualification and monitor of suppliers of products and services concerning the manufacture and control of Medical Devices, and keep up to date the evaluations.
- Ensure that training is carried out as per the annual plan.
Il candidato prescelto
- Bachelor's degree (engineering, a technical field or equivalent)
- 3+ years of experience in working in Quality System related area.
- Experience working in a regulated industry (Medical Device, Pharma, Aerospace, etc)
- Knowledge of Quality System principle for medical device industry preferred (ISO13485 / MDSAP).
- Auditing experience preferred
- Leadership, initiative and accountability;
- Experience in preparing data and charts
- Excellent organizational skills, analytical abilities, and ability to multi-task
- Occasional domestic travel required
- Fluent in Italian and English both written and spoken.
Cosa comprende l'offerta
The salary package will be proportionate to the candidate's experience