Introduction

Unilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.

Your Tasks

The quality officer is responsible to active and proactive support of quality assurance for the core laboratories in Coppet and Dübendorf locations through regular visits, audits and continuous support of analytics in the implementation of the requirements according to QUALAB, SWISSMEDIC and ISO 15189.

Key responsibilities

• Oversee the day-to-day quality related operations of the laboratory to ensure that the management system is sustainable and effective.
• Adheres to the standard operating procedures, corporate policies and, and other regulatory bodies.
• Works with department supervisors to assure new procedures are appropriately implemented and documented.
• Monitor the progress of implementation and subsequent use of the document management system.
• Maintains document control system, including review, filing and archiving of data.
• Provides guidance for laboratories in implementing policies with respect to regulatory and accreditation requirements.
• Participates in the development and improvement of the management system.
• Trains staff 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 and follows-up with the laboratories for all quality related topics (non-conformance, adverse events, corrective and preventive actions, change management)
• 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.
• Ensures 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 or Master’s degree (or equivalent) in life science, medical laboratory science or quality
• Fluent in English, speaks professionally French and/or German
• Minimum 1 year of relevant experience in a Quality position within a life science industry, or 1 year of laboratory experience within a clinical diagnostics laboratory
• Knowledge of ISO 15189, ISO17025 and IVDR (or ISO 13485) is a plus
• Good MS Office knowledge

Required 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.
• Willingness to travel between Coppet and Dübendorf (20 to 25% of the time)
• 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

Contact details

Mr Antonio Gambin,