Senior Manager, Quality Operations & Release

ONWARD Medical; Lausanne; On-site; CHF 180,000 - 260,000; Full time

Job summary

ONWARD Medical is seeking a Manager of Quality Operations to lead QC, SQE, and oversight of CMOs, ensuring full regulatory compliance for product release. You will supervise a team of Quality Engineers and Technicians and collaborate with Procurement, Supply Chain, R&D, and Manufacturing to maintain production quality.

The role requires a Master’s degree in Engineering or Life Sciences, 8+ years in quality roles within electromechanical medical devices, and 3+ years in leadership.

Qualifications

• Master’s degree in Engineering, Life Sciences, or related discipline.
• Minimum 8 years of quality experience in electromechanical medical devices, with at least 3 years in a leadership role.
• Proven experience managing CMOs and suppliers in a regulated environment.
• Solid understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory frameworks.
• Hands-on experience with SCR processes, CAPA, risk management, and process validation.
• Fluent in English; other languages are a plus.

Responsibilities

• Oversee Quality Operations across internal and external manufacturing partners (CMOs).
• Ensure manufacturing and assembly activities comply with ISO 13485 and FDA regulations.
• Review and approve DHRs, batch records, and Certificates of Analysis/Conformance.
• Lead investigations into supplier nonconformances and drive CAPA actions.
• Manage deviations, nonconformances, and CAPAs related to production and incoming materials.
• Act as final quality approver for product releases and sign off on batch release documentation.

Skills

Leadership

Quality Operations

Regulatory compliance

Supplier quality

Project management

English fluency

Education

Master’s degree in Engineering/Life Sciences

Tools

8D

FMEA

SPC

SCR processes

CAPA

Job description

ONWARD Medical is seeking a Manager of Quality Operations to lead QC, SQE, and oversight of CMOs, ensuring full regulatory compliance for product release. You will supervise a team of Quality Engineers and Technicians and collaborate with Procurement, Supply Chain, R&D, and Manufacturing to maintain production quality.

The role requires a Master’s degree in Engineering or Life Sciences, 8+ years in quality roles within electromechanical medical devices, and 3+ years in leadership.