Quality System Lead

Danaher - Global; Vaughan; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading company in life sciences and diagnostics seeks a Quality System Lead to support global Quality Management System initiatives. This on-site role involves maintaining the Electronic Document Management System, leading audits, and ensuring compliance with industry standards. Candidates should have a Bachelor's degree and over 5 years of relevant experience in manufacturing.

Benefits

Comprehensive healthcare benefits

Paid time off

Qualifications

• 5+ years of experience in manufacturing, preferably in instruments, medical devices, or life sciences manufacturing.
• Experience leading QMS audits.

Responsibilities

• Maintain and improve the Electronic Document Management System (EDMS).
• Act as the Global Audit Process SME and lead internal audits.
• Write and maintain QMS procedures.

Skills

Proficiency with MS Office

Quality tools (Minitab, FMEA, SPC, DOE)

Understanding of ISO9001

Understanding of ISO13485

Understanding of FDA 21 CFR Part 820

Education

Bachelor’s degree in science, engineering, or equivalent

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology?

At SCIEX, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As part of SCIEX, you will influence life-changing research and outcomes while accelerating your potential. For over 50 years, we have empowered our customers to solve impactful analytical challenges through groundbreaking innovation and outstanding support. You will be part of a winning team, enabled by DBS, passionate about helping life science experts worldwide get trustworthy answers.

Learn about the Danaher Business System, which makes everything possible.

Position: Quality System Lead

The Quality System Lead supports global Quality Management System (QMS) initiatives and continuous improvement activities (e.g., Kaizen, PSP) at SCIEX. This role collaborates with QMS leadership for status updates, escalations, and process improvements.

This position reports to the Sr. Manager, Quality Management System, and is part of the Quality Assurance & Regulatory Affairs (QARA) team located in Concord, Ontario, Canada. It is an on-site role.

In this role, you will:

• Maintain and improve the Electronic Document Management System (EDMS).
• Act as the Global Audit Process SME and lead internal audits.
• Assist in root cause investigations, action planning, implementation, and effectiveness verification.
• Write and maintain QMS procedures.
• Ensure compliance with ISO9001, ISO13485, FDA 21 CFR Part 820, and other standards.

Minimum requirements:

• Bachelor’s degree in science, engineering, or equivalent.
• 5+ years of experience in manufacturing, preferably in instruments, medical devices, or life sciences manufacturing.
• Proficiency with MS Office and quality tools (Minitab, FMEA, SPC, DOE).
• Good understanding of ISO9001, ISO13485, and FDA 21 CFR Part 820 standards.
• Experience leading QMS audits.

Travel:

• Approximately 3 or more trips per year to the U.S. and Singapore.

Preferred experience:

• Project management.
• Working in a global environment.

SCIEX offers comprehensive benefits, including healthcare and paid time off. Learn more at Danaher Benefits Info.

#LI-LCS

Join our team to accelerate the impact of science and technology. We partner globally to solve complex challenges and bring science to life.

For more information, visit www.danaher.com.

We are committed to equal opportunity employment and value diversity in our workforce. Reasonable accommodations are available for applicants with disabilities. Contact [e-mail] for assistance.