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.
Was Sie mitbringen
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.
Was wir Ihnen bieten
Ein spannendes und dynamisches Arbeitsumfeld mit viel Internationalität
Übernahme von Verantwortung und die Entfaltung deines Potentials
Ein positives Arbeitsklima mit einer partnerschaftlichen Zusammenarbeit und einer wertschätzenden und anerkennenden Firmenkultur
Attraktive Fringe Benefits sowie eine 40h Woche und 5 Wochen Ferien
Jahrespauschale für Ihre persönlichen Analysen und Spezialpreise für radiologische Beratung bei der Unilabs-Gruppe
