Quality Engineer

Job Title: Senior 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.

Key Responsibilities:

• Facilitate root cause analysis using methodologies such as, 5 Why Analysis, Fishbone (Ishikawa) Diagram, Fault Tree Analysis, Pareto Analysis
• Manage the complete CAPA lifecycle & Ensure CAPAs comply with regulatory requirements including CAPA metrics and identify recurring quality issues.
• Support internal, external, customer, and regulatory audits related to CAPA activities.
• Conduct and maintain risk management activities throughout the product lifecycle.
• Perform risk assessments using, FMEA (Failure Modes and Effects Analysis), Risk Hazard Analysis, Fault Tree Analysis, Risk-Benefit Analysis
• Ensure compliance with International Organization for Standardization ISO 14971.
• Evaluate quality events, complaints, deviations, and audit findings for risk impact.
• Drive risk remediation programs to reduce product and process risks.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Clinical teams to implement controls.
• Verify effectiveness of risk control measures.
• Maintain Risk Management Files and Risk Registers.
• Support business quality initiatives during organizational changes, mergers, acquisitions, site transfers, or system migrations.
• Ensure quality system requirements are maintained during migration activities.
• Review and approve validation documentation for migrated systems.
• Support transition of quality processes, procedures, and records between sites or systems.
• Perform gap assessments and remediation planning.
• Coordinate change control activities associated with migration projects.
• Ensure data integrity, traceability, and regulatory compliance during migration

Benefits:

• Competitive salary package.

• Health insurance coverage.

• Career growth opportunities.

• Employee recognition & rewards.

• Friendly and collaborative work culture

Work Model: Onsite

Application Process / Equal Opportunity Statement:

To apply for this position, please submit your application through job portals or by email to hiring@novintix.com. Applications received through these channels will be reviewed, and shortlisted candidates will be contacted for screening and interview rounds. Only shortlisted candidates will be contacted for further steps.

NovintiX Technologies is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, or any other protected characteristic.