Global Device Supplier Quality Manager

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

Job summary

Hoffmann-La Roche Ltd. in Mississauga is seeking a Device Quality Manager to drive quality assurance across external suppliers and contract manufacturers, ensuring compliance with global regulations for medical devices and combination products.

You will lead quality activities across the supplier lifecycle, manage change controls and deviations, and coordinate quality support between global device teams and local site teams for clinical and commercial releases. Travel up to 30% is required.

Qualifications

• Degree in engineering, life sciences, or related field with 5–7 years in quality compliance or supplier oversight in biotech/medical devices.
• Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and ISO 14971, with risk management and design control concepts.
• Effective communicator who translates complex quality requirements into guidance; willingness to travel up to 30%.

Responsibilities

• 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.

Skills

Quality management

Regulatory knowledge

Stakeholder collaboration

Root cause analysis

Travel readiness

Education

Bachelor's degree in engineering or life sciences

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.

We use artificial intelligence to screen, assess or select applicants for this role.

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.