Quality Officer – Quality Management System

Job Description

Introduction

Unilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.

 

Your Tasks

  • Maintains document control system, including review, filing and archiving of data.
  • Participates in the development and improvement of the management system.
  • Trains staff or coordinates training in assigned department on Quality policies and procedures.
  • Analyzes data, tracks / trends issues to identify gaps in processes, training, and helps create solutions through improvement process.
  • Supports the quality managers with all quality system related topics (non-conformance, adverse events, corrective and preventive actions, change management)
  • Coordinates closure of quality management system records (non- conformances, adverse events, changes etc…)
  • Tracks and follows-up
  • Supervises all Quality practices and supports end-users to ensure high quality laboratory services.
  • Keeps Quality Manager informed of any significant issues affecting overall laboratory quality including but not limited to audit findings, validations, corrective and preventative actions.
  • Collects information for Annual Management Review (AMR), follow up on projects, objectives, manage AMR output (projects, tasks, action items); share data to relevant departments.
  • Assists with internal audits. Performs audits in assigned laboratory and or department as directed.
  • Supports/coordinates with quality managers complete and accurate readiness for all inspections and maintains all necessary documents.
  • Participates in regulatory and accrediting agency inspections when needed
  • Draft responses to regulatory inspection.
  • Prepares filing for necessary licensure, certification and/or accreditation as appropriate for the laboratory’s test complexity.
  • Performs special projects as assigned.
  • Actively participates as a member of the Quality Team.

Your Profile

Education and Experience

  • Bachelor’s degree (or equivalent) in life science, medical laboratory science or quality
  • Fluent in French and German, speaks professionally English is a plus
  • Minimum 2 years of relevant experience in a Quality position within a life science industry
  • Knowledge of ISO 15189, ISO17025 and IVDR (or ISO 13485)
  • Good MS Office knowledge

Skills

  • Good analytical and problem-solving skills.
  • Good interpersonal skills.
  • Good communication skills with ability to communicate with internal and external stakeholders.
  • Good coordination and planning skills.
  • Rigorous, organized and high level of attention to detail.
  • Ability to work independently and initiate contacts as necessary.
  • Good team player.

We Offer

  • An exciting and dynamic work environment with a lot of internationality
  • Taking responsibility and unfolding your potential
  • A positive working atmosphere with a partnership and appreciative corporate culture
  • Attractive fringe benefits as well as a 40-hour week and 5-weeks vacation
  • Annual fee for your personal analyses and special prices for radiological advice from the Unilabs Group

OST – Ostschweizer Fachhochschule
Herr Gunnar Heipp

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