Q&A Specialist

Offerta pubblicata in data:
Luogo di Lavoro:
Roma
Offerta:

Randstad Technologies, la divisione specializzata nella ricerca e selezione di profili IT di Randstad Italia, ricerca per cliente finale nel settore della  Ricerca & Sviluppo, progettazione e produzione sw in ambito Medical un ingegnere esperto di processi di Q&A con esperienza in ambito produttivo/medicale

Di seguito il dettaglio delle responsabilità e delle competenze richieste al candidato ideale:

Main Tasks and Responsibilities:

Concerning the strategies assigned by the Company Direct Manager:

  • Report directly to the quality team Leader for all operations related to quality management system
  • Support the quality team to manage the quality system activities, conformity of operations to standards and applicable regulatory requirements
  • Support the quality team towards Competent Authorities, Notified Bodies, other stakeholders and interested parties
  • Cooperate to maintenance and update of operative procedures, work instructions, verification and validation activities, periodic reporting
  • Cooperate to handling of nonconformities and deviations
  • Cooperate to metrology maintenance activities
  • Cooperate to quality control processes related to acceptance, production, and release of products
  • Monitor and verify proper handling of deviations and nonconformities of internal processes in every area of Company activities
  • Monitor and verify proper handling of customer complaints and on field deviations and nonconformities
  • Cooperate to quality programs for distribution and import activities of third party medical devices
  • Develop experience in quality system operations and strengthen own knowledge of industry standards and best practices
  • Develop deep understanding and working ability to perform change management operations and supervise design quality of medical device projects
  • Develop deep understanding and working ability to effectively contribute in inter-department operations, by studying implications and consequences of any decision step in the Company operations chain and matrix
  • Successfully achieve periodic milestones set within the quality team

Hard Skills

• < 3="" years="" of="" experience="" in="" the="" medical="" device="">
• Working knowledge of ISO 13485 and 9001
• Basic knowledge of medical industry worldwide regulations

Soft Skills

• Excellent writing and verbal communication skills
• Ability to work both in team and alone
• Effective organizational skills
• Advanced PC skills
• Analytical Capabilities
• Open minded and innate willingness to learn

Titolo di studio di provenienza: ingegneria elettronica/automazione

Inglese: fluente

Inquadramento: Tempo Indeterminato
Offerta di lavoro pubblicata da: Hivejobs - Randstad