Quality Officer – Quality Management System

Unilabs Switzerland; Dübendorf; Vor Ort; CHF 60’000 - 90’000; Vollzeit

Zusammenfassung

Unilabs Switzerland is seeking a Quality Coordinator to oversee quality management in laboratory services. Key responsibilities include maintaining document systems, analyzing data, training staff, and participating in audits. The ideal candidate holds a bachelor's degree in life science, has at least 2 years of relevant experience, and is fluent in German and French.

Qualifikationen

• Minimum 2 years of relevant experience in a Quality position.
• Knowledge of ISO 15189, ISO 17025, and IVDR.
• Fluency in German and French, professional English.

Aufgaben

• Maintains document control system, reviews and archives data.
• Trains staff on Quality policies and procedures.
• Supports quality managers with quality system topics.

Kenntnisse

Analytical skills

Problem-solving

Communication

Coordination

Interpersonal skills

Ausbildung

Bachelor’s degree in life science or quality

Tools

MS Office

Jobbeschreibung

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…)
• 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

• Bachelor’s degree (or equivalent) in life science, medical laboratory science or quality
• Fluent in German and French, speaks professionally English
• 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
• 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.