Senior Quality Engineer: CAPA & Audit Lead

STAAR Surgical Company; Schweiz; On-site; CHF 90,000 - 130,000; Full time

Job summary

STAAR Surgical Company is seeking a Quality Engineer to support site production, operations, and quality teams. The role focuses on investigations, CAPA leadership, and the assessment of equipment life-cycle impacts within the medical device manufacturing context.

Responsibilities include leading root cause analyses, initiating corrective actions, and performing internal and supplier audits. Strong communication skills in English and German/French are desired, with proficiency in Windows tools

Qualifications

• Bachelor’s degree in quality, mechanical, life sciences or industrial engineering.
• Solid understanding of quality system regulations for medical devices/pharma.
• Knowledge of investigation techniques including design of experiments and root cause analysis.

Responsibilities

• Lead investigations into product/process nonconformities including root cause analysis and health risk assessment.
• Define requirements and assess impact on equipment lifecycle and processes.
• Prepare and execute validations, tests, and study reports with protocols and acceptance criteria.
• Lead CAPA projects with corrective action plans and effectiveness checks.
• Conduct internal and supplier audits and track corrective actions to closure.

Skills

Quality systems

Investigation techniques

Root cause analysis

CAPA processes

Auditing

Project management

Documentation

Windows software

Education

Bachelor’s degree in quality, mechanical, life sciences or industrial engineering

Tools

FMEA/DOE tools

MS Office Suite

Job description

STAAR Surgical Company is seeking a Quality Engineer to support site production, operations, and quality teams. The role focuses on investigations, CAPA leadership, and the assessment of equipment life-cycle impacts within the medical device manufacturing context.

Responsibilities include leading root cause analyses, initiating corrective actions, and performing internal and supplier audits. Strong communication skills in English and German/French are desired, with proficiency in Windows tools