Descripción del Trabajo
To enhance our team of Quality Management in Bettlach/Grenchen (SO), we are looking for:
Quality Systems Analyst II
Your Responsibilities include and are not limited to:
- Drive the execution of Quality Systems (QS) at site level, including Nonconformities (NC), Corrective and Preventive Action (CAPA), Internal and External Audit (IA) Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, Quality Progress Review (QPR) and Quality System Management Review (QSMR) to ensure systems meet all business and regulatory requirements.
- Serving as a SME for NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, Document Control, QPR and QSMR process during audits; supporting the investigation, response and remediation of site-specific QS audit observations.
- Manage the performance and communication of QS metrics to the site management.
- Support site readiness in the deployment of these QS initiative.
- Support compliance and continuous improvement of the Quality System.
- Support document control area where needed.
- Ensuring effective completion of activities.
- Ensuring timely escalation of product quality and compliance issues to proper source
- Two (2) years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is required
- Experience in working in a manufacturing / operations environment is preferred
- Knowledge of ISO and QSR regulations is required
- Experience in Quality Auditing and notified body inspections is preferred
- Experience with root cause investigation, change management, risk management and technical writing is required
- Experience in Quality Systems process development, support, integration or enhancement is preferred
- Experience in Project Management is preferred
- A Certification in process excellence is preferred
- Advanced use of computer and software applications is required
- Language: fluent German and English, French is a plus
What we offer:
- Global company with local roots
- Professional working environment that prides itself in awarding long-term service
- Career progression and development
- Job rotations and internal mobility
- On-job, in-class and online trainings
- International environment and network
- Safe space for creative thinking and on-the-job learning
- Off-site team building events
- Celebrating learning and success
Interested? We are looking forward to your application!