Állásleírás

Global Quality Manager - Medical Devices

Procurement Milano, Lombardia


Leírás

Who we are

Amplifon is an Italian multinational company and the global leader in hearing care solutions and services for retail expertise, customization and consumer care. More than 17,000 professionals every day in a network of 4,500 points of sale, 3,800 service centers and 1,900 affiliates, give back the joy of hearing, feeling and living to thousands of people across the world.

In Amplifon we believe people are the most important component of our success. Thanks to our best-in-class Hearing Care Professionals and front and back office Teams, we are able to put the everyday taps, pops and splashes back into the lives of our customers. We believe that it’s only through strong investment in talent engagement, continuous professional development, support and recognition that our people can exceed every limit and build a fulfilling career.


What we are looking for

We are seeking a solid professional experienced in the Medical Device industry, in particular expert in class IIa devices to set up the quality department within the Global Product Development function.

The incumbent will be:

  • Responsible for Product Quality, Process Quality and Suppliers Quality
  • Leads the implementation and ensures compliance to the company's integrated system of procedures and standards according to MDD/MDR
  • Expert in ISO 13485, ISO 9001
  • Supports New Product Development projects, with the aim to get all the certification required, as well as maintain existing certifications
  • Manages suppliers’ system and non-conformance system
  • Develops quality metrics, and coordinates quality data collection and analyses for Management Reviews
  • Manage priorities, eliminate bottlenecks and address critical issues
  • Proposes relevant changes to continuously improve processes, methods and practices of QA
  • Provides support in the Industrialization / Engineering of new products and the implementation of processes or materials, supervising process performance

What you'll need

  • Minimum 7 years' related experience in a regulated environment
  • Experience in the Quality department of an ISO certified manufacturing company preferably in the B2B Electronics
  • Management experience highly preferred
  • Direct Quality Control Experience
  • Strong oral and written communication skills
  • Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations

Skills

  • Strong oral and written communication skills
  • English (very fluent); second language is a preference, but not a must
  • Proactive, energetic and willing to enlarge own competence through constant learning
  • Strong presentation and meetings management skills
  • Able to cope with diverse environment (different cultures; level of capabilities etc)
  • Leadership blended with focus on results, influencing and agility
  • Mobile and open to travel
  • Must have proved communication and team building skills
  • Ability to be hands-on