Quality Engineer

Onward Medical seeks a Quality Engineer in Lausanne to oversee supplier and CMO quality, ensuring regulatory compliance and product release.

This position acts as the primary connection between Onward Medical and its external manufacturing partners. The engineer is responsible for guaranteeing that all products from suppliers and contract manufacturers adhere to strict regulatory, quality, and business standards. The role provides critical oversight across the entire manufacturing process, from incoming material inspection to final product release.

Responsibilities

• Partner with contract manufacturing organizations (CMOs) and suppliers to verify that quality standards are maintained throughout the product lifecycle.
• Review and approve manufacturing batch records to confirm adherence to Good Manufacturing Practices (GMP) and internal protocols.
• Assist with incoming inspection tasks, such as evaluating Certificates of Analysis (CoAs) and material certifications.
• Engage in nonconformance reviews and dispositions, performing root cause analysis and managing Corrective and Preventive Actions (CAPA).
• Oversee or support equipment qualification and process validation efforts (IQ/OQ/PQ) at supplier locations.
• Support or lead batch release processes, including the review of Device History Records (DHRs) and verification of quality control test results.
• Coordinate with Regulatory Affairs, Procurement, and Manufacturing departments to facilitate timely product releases.
• Take part in supplier audits, readiness assessments, and initiatives aimed at quality improvement.
• Ensure strict compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and internal Quality Management System (QMS) policies.
• Maintain precise quality documentation and records in line with document control standards.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 3–5 years of experience in Quality Assurance.
• Knowledge of ISO 13485, FDA QSR, and GxP regulations.
• Experience working with CMOs and suppliers in a regulated environment.

Nice to have

• Experience with quality management systems (e.g., MasterControl, TrackWise, Veeva, or similar).