Quality Specialist

To expand the Operations team we are looking for a Quality Specialsit. He/he will report directly to the Head of Operations and have the opportunity to manage all the aspects of our Company Quality

Main responsibilities:

  • Management and development of Quality Systems (ISO 9001, 13485 and FDA)
  • Drafting and updating of system documentation and management reports, in support of internal managers
  • Collaboration with the R&D team, especially our Regulatory Affairs, in order to manage the audits preparatory to obtaining certifications
  • Management and qualification of suppliers and drafting of quality agreements in collaboration with the legal department
  • Mapping of management processes, collection and analysis of the needs of internal managers, preparation of reports with implementation actions with a view to continuous improvement
  • Collaboration with all company departments on transversal issues (e.g. environment, security, privacy, human resources, organizational model Legislative Decree 231, ICT)
  • Management and maintenance of measuring instruments
  • Coordination of Quality Control activities of outgoing products
  • Management of quality improvement projects (Complaints & NC reductions, CAPA, …).
  • Management of preparatory activities for management review

Requirements:

  • Degree in Engineering or equivalent culture
  • Previous experience, at least 1 or 2 years, in the management of company Quality Systems
  • Knowledge of UNI EN ISO 9001 (UNI EN ISO 13485 and FDA as plus)
  • Good knowledge of English
  • Good knowledge of the Office package and the most common IT tools

Preferred:

  • Knowledge of Lean Six Sigma

We are looking for candidates with:

  • Propensity for continuous improvement
  • Strong analytical and problem solving skills
  • Excellent interpersonal communication and teamwork skills
  • Attention to detail 

Like everyone at Digitec, the Quality Specialist will promote the core values of our culture, namely Integrity, Vision, Teamwork, Innovation, Leanthinking and Passion. 

What we offer:

  • Induction path
  • Stimulating context, constantly evolving
  • Training to increase technical and soft skills
  • Possibility of growth in a managerial role
  • Excellent business climate that allows you to work peacefully giving your best
  • Flexible working hours and 3 days in smart working weekly
  • …Changing rooms and showers in Company Building that allow athletes to train during their lunch break.

Let's work together