13 - 17 July

Join us at ECR 2022!

Quality Manager

We are looking for a Quality Manager. He/She will report directly to the Managing Director, work with all company departments and coordinate a resource dedicated to Quality Control.

Main activities

  • Elaborate and manage the documentation of the company’s Quality Management System (Manual, Procedures, competence modules), so that it complies with the requirements of ISO 13485 and 9001
  • Elaborate, independently or on the basis of the indications of any users, the quality records necessary to ensure the effective functioning of the quality management system ensuring its distribution and management in a controlled form
  • Manage the regulations concerning the quality management applicable in the company, ensuring their updating and correct archiving
  • Analyze the elements leaving the business processes (including elements of external origin such as customer complaints) in order to create a source of information that can be used by the Management as an input element to carry out reviews and for continuous improvement
  • Collaborate with the Purchasing Manager on the qualification and management of the company suppliers and take care of their annual supervision
  • In collaboration with the Technical Manager, take care of the management and updating of the system documentation relating to the measurement instrumentation
  • Plan internal audits on all aspects of the documentation and registration system and audits to suppliers, to verify that the activities carried out for quality give results in accordance with what is planned, the requirements of the reference standard and those expressed by customers
  • Be a point of reference for the registration and management of complaints and non-compliant situations, the analysis of which can give rise to corrective actions
  • Perform or guarantee internal audits and audits to suppliers, or support external personnel specifically appointed by the Management in this regard
  • Identify actions to eliminate potential causes of non-compliance by taking the necessary actions to prevent their occurrence (preventive actions)
  • Ensure the registration of the training carried out by Digitec with customers-suppliers
  • Issue the appropriate management documentation such as management review, context analysis and process risk analysis
  • Be a business reference point for business KPIs
  • Carry out the release of the Medical Device lot on behalf of the Management
  • Collaborate with the Management to identify the customer satisfaction monitoring methods.
  • Analyze with the Management the incoming elements of the process related to customer satisfaction in order to monitor the performance of the quality management system and take the appropriate actions.
  • Monitor compliance with company procedures and regulatory requirements

Requirements:

  • Degree in Biomedical Engineering or related culture
  • Knowledge of MDD, ISO 9001, ISO 13485, CE marking of Medical Devices
  • Experience as a Quality Manager in the Medical Devices field
  • Project management experience
  • Good knowledge of the office package and computer systems in general
  • Good knowledge of the office package and computer systems in general
  • Excellent knowledge of English
  • Preferential requirements: specialization as an audit auditor and direct experience as a Quality Manager
  • Appreciated experience in the FDA field
  • Experience as team leader/people manager is welcome
  • Knowledge of Lean Manufacturing is appreciated

Required skills:

  • Excellent relational and communication skills
  • Flexibility and good synthesis ability to create a lean system, easy to apply
  • Ability to work in a team
  • Ability to organize, coordinate and optimize the workflow
  • Be able to analyze and process business processes
  • Good ability to draw up documentation
  • Sense of responsibility, reliability, discretion and confidentiality
  • Resourcefulness
  • Predisposition and problem solving skills

Hybrid working is allowed.

We offer a permanent contract.

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