QA Engineer

• Own supplier quality for a portfolio of critical mechanical, electrical and mechatronic suppliers from supplier qualification through production and continuous improvement
• Define supplier qualification criteria and establish processes for assessing and approving new suppliers
• Prepare and maintain supplier audit and assessment frameworks, including questionnaires and checklists
• Conduct on-site assessments of critical suppliers and drive audit findings through closure
• Monitor supplier performance, identify recurring quality issues and initiate improvement or development actions
• Identify suppliers, manufacturers and service providers requiring Quality Assurance Agreements
• Develop and maintain QAA templates aligned with ISO 9001 and ISO 80079-34 requirements
• Review and negotiate QAA terms with suppliers, covering responsibilities, control points, traceability, non-conformities and other quality requirements
• Coordinate internal Quality, Legal and Purchasing approvals for QAAs and monitor ongoing supplier compliance
• Define and maintain the supplier NCR process from detection and reporting through escalation, follow-up and closure
• Establish NCR templates and tracking tools and communicate non-conformities clearly with suppliers
• Analyse NCR trends and recurring issues to identify systemic quality problems and drive corrective actions
• Initiate supplier development, improvement plans or requalification where supplier performance falls below expectations
• Work closely with Procurement, Engineering, Manufacturing and Quality teams and directly with suppliers to solve quality issues at the source
• Define processes and requirements, audit suppliers, drive corrective actions and ensure improvements are implemented and sustained

Supplier Quality Engineer

• QA oversight of qualification and validation activities for GMP-relevant facilities and equipment, with a focus on solid dosage forms and packaging, as well as simple CSV systems (GAMP 5 Categories 1 and 3)
• Supporting the implementation of data integrity requirements
• Maintaining the Right to Operate through end-to-end cGMP activities
• Reviewing and approving GMP documents, including qualification plans, CAPAs, SOPs, change and deviation management documentation, and risk assessments
• Conducting in-depth root cause analyses to resolve complex issues
• Driving optimization and improvement activities within IMP Quality
• Working closely with stakeholders to achieve shared goals
• Representing the area of responsibility during health authority inspections and internal audits

QA Engineer jobs in Switzerland

Supplier Quality Engineer

Technical QA Manager – Facilities and Systems