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