Manager Quality Operations

Onward Medical seeks a Manager of Quality Operations in Lausanne to lead QC, product release, and supplier oversight, ensuring strict compliance with ISO 13485 and FDA regulations.

This position is responsible for directing all facets of quality operations, including quality control, product release, supplier quality engineering, and the management of contract manufacturing organizations. The role ensures that all manufactured products meet regulatory standards and holds final authority for releasing products to the market.

Responsibilities

• Direct daily quality activities for internal processes and external manufacturing partners.
• Verify that assembly and manufacturing steps adhere to ISO 13485, FDA 21 CFR Part 820, and other relevant rules.
• Approve Device History Records, lot release papers, and Certificates of Analysis.
• Provide oversight for technology transfers, process validations, and change controls involving suppliers.
• Work with Procurement, Supply Chain, R&D, and Manufacturing teams to maintain production quality.
• Handle quality processes such as deviations, nonconformances, and CAPAs for production and materials.
• Supervise the inspection and testing of incoming materials, in-process items, and finished goods.
• Ensure that testing protocols are validated and consistently applied.
• Analyze inspection data trends to drive necessary quality improvements.
• Qualify, audit, and monitor suppliers, distributors, and CMOs for compliance.
• Maintain Quality Agreements, define inspection criteria, and evaluate supplier performance.
• Manage Supplier Change Requests to ensure proper risk evaluation and approval.
• Lead investigations into supplier nonconformances, including root cause analysis and corrective actions.
• Drive supplier development through structured performance management and continuous improvement.
• Serve as the final approver for product release, ensuring compliance with specifications and regulations.
• Sign off on batch release documentation and support regulatory submissions.
• Lead, mentor, and support a team of Quality Engineers and Technicians.
• Allocate tasks and resources to meet department goals and deadlines.
• Foster a proactive, quality-focused culture throughout the organization.

Requirements

• Master’s degree in Engineering, Life Sciences, or a related field.
• At least 8 years of experience in quality roles within the electromechanical medical device industry.
• Minimum of 3 years in a leadership position.
• Proven experience managing CMOs and suppliers in a regulated environment.
• Strong understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory frameworks.
• Hands-on experience with Supplier Change Request (SCR) processes, CAPA, risk management, and process validation.
• Proficiency with quality tools such as 8D, FMEA, and SPC.
• Fluent in English.

Nice to have

• Knowledge of additional languages is an advantage.

About the company

Onward Medical fosters a proactive, quality-focused culture throughout the organization, emphasizing continuous improvement and strict adherence to regulatory standards in all operations.

• Promotes a proactive, quality-focused culture across the organization.