Global Device Quality Manager: Lead Supplier Excellence

Roche; Mississauga; On-site; CAD 106,000 - 139,000; Full time

Job summary

Roche is seeking a Device Quality Manager to join Global Device Quality Management. You will provide quality assurance oversight for external suppliers and contract manufacturers, lead supplier lifecycle quality activities, and manage change controls to sustain compliance.

You will coordinate with cross-functional teams across clinical and commercial releases, driving continuous improvement and proactive issue resolution.

Qualifications

• You bring a degree in engineering, life sciences, or a related field, with 5-7 years of experience in quality compliance or supplier oversight.
• Strong knowledge of international quality standards and regulatory frameworks (ISO 13485, 21 CFR 820, EU MDR, ISO 14971) and risk management concepts.
• Effective communicator and collaborator who translates complex quality requirements into guidance; proactive problem-solver.

Responsibilities

• Provide quality assurance oversight for external suppliers and contract manufacturers to ensure compliance with global regulations and standards.
• Lead quality activities across the supplier lifecycle, including audit support, investigation oversight, complaint handling, and method validation review.
• Oversee change controls and deviations while facilitating root-cause analysis to improve product quality and compliance.
• Coordinate quality support between global device teams and local site teams responsible for clinical and commercial releases.
• Collaborate with cross-functional stakeholders to set priorities, meet milestones, and resolve quality or regulatory issues proactively.
• Leverage digital and continuous improvement methodologies, including Agile and lean tools, to optimize quality workflows.

Skills

Quality assurance

Supplier oversight

Regulatory compliance

Audit support

Root cause analysis

Cross-functional collaboration

Travel readiness

Education

Engineering or Life Sciences degree

Tools

Quality Management System (QMS)

Regulatory knowledge (ISO 13485, 21 CFR 820)

Job description

Roche is seeking a Device Quality Manager to join Global Device Quality Management. You will provide quality assurance oversight for external suppliers and contract manufacturers, lead supplier lifecycle quality activities, and manage change controls to sustain compliance.

You will coordinate with cross-functional teams across clinical and commercial releases, driving continuous improvement and proactive issue resolution.