Overview
Junior Quality Engineer Jobs in Zuchwil, Solothurn, Switzerland at NovintiX
Title: Junior Quality Engineer
Company: NovintiX
Location: Zuchwil, Solothurn, Switzerland
Job Title: Quality Engineer
Location: Switzerland (Le Locle and Zuchwil)
About the Company:
NovintiX is a fast-growing engineering and digital transformation company serving top Life Sciences, MedTech, and Healthcare clients across the US, Ireland, and Europe. We specialize in delivering high-impact digital programs, engineering services, and talent solutions that accelerate innovation, efficiency, and compliance.
Role Summary
Develops and maintains labels for complex medical devices. Collaborates with product subject matter experts to gather and assess labelling content providing best practices and standardization across our global business. Executes label format and compiles content using specialized software. Audience for labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements. This role is specialized.
Job Description – Quality Engineer, 2+ years (Medical Devices / Healthcare Domain)
Responsibilities
- Investigate product, process, supplier, and quality system non-conformances.
- Conduct root cause analysis using tools such as 5 Whys, Fishbone Diagram, and Fault Tree Analysis.
- Initiate, manage, and track Corrective and Preventive Actions (CAPA) through closure.
- Verify effectiveness of implemented CAPAs and ensure timely completion.
- Analyze quality trends and recurring issues to drive continuous improvement.
- Support internal, customer, and regulatory audits related to NC and CAPA activities.
- Ensure compliance with quality standards such as International Organization for Standardization ISO 13485 and U.S. Food and Drug Administration FDA regulations.
- Perform risk assessments throughout the product lifecycle.
- Develop and maintain Risk Management Files in accordance with International Organization for Standardization ISO 14971.
- Conduct Failure Mode and Effects Analysis (FMEA), Hazard Analysis, and Risk Assessments.
- Evaluate quality events, complaints, deviations, and audit findings for risk impact.
- Drive risk mitigation and remediation activities to reduce patient, product, and business risks.
- Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Operations.
- Monitor effectiveness of risk control measures and update risk documentation accordingly.
- Support quality activities during business transformation, acquisitions, site transfers, and system migrations.
- Conduct quality impact assessments for process and system changes.
- Support migration of quality records, documentation, and data while ensuring data integrity.
- Participate in validation and verification activities for migrated systems.
- Coordinate change control activities associated with migration projects.
- Identify compliance gaps and drive remediation actions.
- Ensure continuity of quality management system processes during migration activities.
