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.
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