At Unilabs, we are the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland, employing around 800 people.
Your Key Responsibilities
* Maintain our document control system, including reviewing, filing, and archiving data accurately.
* Contribute to the development and improvement of our management system, ensuring seamless operations.
* Train staff or coordinate training in assigned departments on quality policies and procedures.
* Analyze data, identify trends, and gaps in processes to develop targeted solutions.
* Support quality managers with all quality system-related topics, including non-conformances, adverse events, corrective actions, and change management.
* Closure coordination for quality management system records (non-conformances, adverse events, changes etc.)
* Data tracking and follow-up
* Ensure high-quality laboratory services by supervising all quality practices and supporting end-users.
* Inform the Quality Manager of significant issues affecting overall laboratory quality, including audit findings, validations, and corrective actions.
* Gather information for Annual Management Review (AMR), track projects, objectives, manage AMR output, and share data with relevant departments.
* Assist with internal audits and perform audits in assigned laboratories or departments as directed.
* Support/coordinate complete and accurate readiness for all inspections and maintain necessary documents.
* Participate in regulatory and accrediting agency inspections when needed.
* Draft responses to regulatory inspection.
* Prepare filings for necessary licensure, certification, and/or accreditation for test complexity.
* Perform special projects as assigned.
About You
Education and Experience
* Bachelor's degree (or equivalent) in life science, medical laboratory science, or quality.
* Fluent in French and German; English proficiency is a plus.
* Minimum 2 years of experience in a quality position within a life science industry.
* Knowledge of ISO 15189, ISO17025, and IVDR (or ISO 13485).
* Good MS Office skills.
Skill Set
* Strong analytical and problem-solving skills.
* Excellent interpersonal skills.
* Effective communication skills for internal and external stakeholders.
* Strong coordination and planning abilities.
* Rigorous, organized, and attention to detail.
* Ability to work independently and initiate contacts as needed.
* Team player.
We Offer
* A dynamic work environment with international collaboration.
* Taking ownership and developing your potential.
* A positive working atmosphere with partnership and appreciative culture.
* Competitive fringe benefits, a 40-hour week, and 5 weeks' vacation.
* Annual fee for personal analyses and special prices for radiological advice from the Unilabs Group.