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Quality Officer – Quality Management System, Bern Client: Location: Job Category: Other
Job Reference: d6de7865f1d1
Job Views: 8
Posted: 23.03.2025
Expiry Date: 07.05.2025
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; professional English is a plus.
Minimum 2 years of relevant experience in a Quality position within a life science industry.
Knowledge of ISO 15189, ISO 17025 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.
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