Quality System Lead

AB Sciex; Ontario; On-site; CAD 80,000 - 110,000; Full time

Job summary

AB Sciex is seeking a Quality System Lead to support global Quality Management System initiatives. This on-site role in Concord, Ontario, involves maintaining the Electronic Document Management System, leading audits, and ensuring compliance with key quality standards. Ideal candidates will have a Bachelor's degree in science or engineering and 5+ years of experience in the medical devices or life sciences sector.

Benefits

Comprehensive healthcare benefits

Paid time off

Qualifications

• 5+ years of experience in a manufacturing environment, preferably medical devices or life sciences.
• Experience leading QMS audits.
• Good understanding of quality management standards.

Responsibilities

• Maintain and improve the Electronic Document Management System (EDMS).
• Lead internal audits and assist in root cause investigations.
• Write and maintain QMS procedures.

Skills

Proficient in MS Office

Quality tools

Good understanding of ISO9001

Good understanding of ISO13485

Good understanding of FDA 21 CFR Part 820

Education

Bachelor’s degree in science or engineering

Tools

Minitab

FMEA

SPC

DOE

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, reliability, and support. Join 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

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

This position reports to the Senior 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 a manufacturing environment, preferably medical devices or life sciences.
• Proficient in MS Office and quality tools (e.g., 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 additional experience:

• Project management.
• Working in a global environment.

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

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Join our team today. Together, we’ll accelerate the impact of science and technology. We partner globally to solve complex challenges, bringing science to life.

For more information, visit www.danaher.com.

Danaher Corporation and its affiliates are committed to equal opportunity and value diversity. We provide reasonable accommodations for individuals with disabilities. Contact [e-mail] for assistance.