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Job Description:

We are searching for the best talent for a Quality Systems Analyst II located in Oberdorf (Basel Land), Switzerland.

This is a fixed term contract that will run until December 2026.

The Oberdorf Quality Systems Team is responsible for the compliance and continuous improvement of the site’s Quality System (QS). In this role, you will work in a collaborative environment with various stakeholders and get hands-on experience with internal and external audits. The Quality Systems Analyst II will drive the execution of the QS at the site level, including Nonconformances (NC), Corrective and Preventive Action (CAPA), Internal Audit (IA) Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, Quality Progress Review (QPR), Quality System Management Review (QSMR), and Records Management to ensure the QS meets all business and regulatory requirements. You will also manage the performance and communication of Oberdorf QS metrics, as well as support site readiness in the deployment of QS initiatives.

As a Quality Systems Analyst, you will:

• Ensure consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC, CAPA, IA Observations. This includes, but is not limited to:
  • Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR and QSMR documentation
  • Assist with the development and documentation of problem statements, bounding, containment, risk assessments, investigation, and action plan determination (corrections, corrective actions, preventive actions, and effectiveness monitoring)
  • Ensure effective completion of activities
  • Provide guidance to record owners for appropriate documentation and compliant execution of procedures
• Coordination, preparation, facilitation, execution, and tracking of activities of the Quality Progress Review (QPR) and Quality System Management Review (QSMR).
• Have oversight and support the tracking of QS metrics at site level. Communicate status and issues to stakeholders and management, as needed.
• Support site Records Information Management activities.
• Provide guidance on requirements and develop the competency of resources that execute the aforementioned QS processes.

Qualifications

• University/Bachelor’s Degree or Equivalent preferred (e.g., Technical Qualification with Further Education)
• Two (2) years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience
• Experience in technical writing, such as root cause investigations of NCs, CAPAs, and Observations
• Awareness of ISO standards and Quality System regulations
• Advanced use of computer and software applications (e.g. Microsoft PowerPoint, Word, Excel, SharePoint, and Teams)
• Soft Skills
• Detail-oriented and high level of accuracy
• Pro-active approach to execution of deliverables and managing stakeholders
• Time-oriented (i.e. able to recognize and adhere to strict timelines)
• Strong communication and interpersonal skills (collaboration with multiple stakeholders is required)
• Ability to follow-up with management-level stakeholders, and challenge, as necessary to ensure compliance to procedural requirements
• Strong English-proficiency is required for the role (successful candidate must be able to facilitate meetings and write documentation in English)

Preferred:

• German-proficiency is advantageous
• Experience facilitating or supporting Management Reviews or Quality Metric Reviews
• Experience in working in a manufacturing/operations environment
• Experience in Quality Systems process development and improvement
• Experience in Quality and notified body inspections