Global Device Supplier Quality Manager

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Opportunity

As an integral part of Global Device Quality Management, the Device Quality Manager collaborates provides:

• Provide quality assurance oversight for external suppliers and contract manufacturers to ensure compliance with global regulations and standards across medical devices and combination products
• Lead quality activities across the full supplier lifecycle, including audit support, investigation oversight, complaint handling, and method validation review
• Oversee change controls and deviations while facilitating systematic root cause analysis to drive continuous 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 and project teams to set clear priorities, meet key milestones, and resolve potential quality or regulatory issues proactively
• Leverage modern digital and continuous improvement methodologies, including Agile practices, lean tools, and artificial intelligence, to optimize quality workflows

Who You Are

• You bring a degree in engineering, life sciences, or a related field, alongside solid 5-7 years of experience in quality compliance, quality engineering, or supplier oversight within the biotechnology, medical device, or combination product industries
• You possess strong working knowledge of international quality standards and regulatory frameworks (such as ISO 13485, 21 CFR 820, EU MDR, and ISO 14971) and understand risk management and design control concepts
• You are an effective communicator and collaborator who thrives in team-oriented environments and can translate complex quality requirements into clear guidance
• You demonstrate strong problem-solving skills with practical experience applying root cause analysis, investigation techniques, or process validation tools
• You are comfortable traveling up to 30% to support supplier interactions and quality initiatives

This position requires up to 30% travel.

The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.