Concord, Ontario, Canada
2 days ago
Quality System Lead

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 you and your unique viewpoint matter. And 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 help to influence life changing research and outcomes, while accelerating your potential. For more than 50 years, we have been empowering our customers to solve the most impactful analytical challenges in quantitation and characterization through ground-breaking innovation and outstanding reliability and support. You will be part of a winning team, enabled by DBS, that is passionate about helping life science experts around the world get to answers they can trust.

Learn about the Danaher Business System which makes everything possible.

The Quality System Lead is responsible for supporting global Quality Management System (QMS) initiatives and continuous improvement activities (e.g., Kaizen, PSP) at SCIEX. This role will have the opportunity to collaborate 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 and will be an on-site role.  

In this role, you will have the opportunity to:

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 regulatory standards.

The essential requirements of the job include:

Bachelor’s degree in science, engineering or equivalent.

5+ years of experience in a manufacturing environment, preferably instruments, medical device or life sciences manufacturing

Adept at using MS Office products (Word, Excel, etc.) and other quality tools (Minitab, FMEA, SPC, DOE, etc.)

Good understanding of the following QMS standards: ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820

Experience in conducting/leading QMS audits

Travel Requirements:

Ability to travel approximately 3 (or more) times per year to the United States and Singapore.

It would be a plus if you also possess previous experience in:

Project management

Working in a global environment

SCIEX, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com. 

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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