Senior Quality Assurance Specialist

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

Job summary

A leading company in life sciences, Danaher is looking for a Senior Quality Assurance Specialist to manage activities related to customer feedback and quality agreements. This role involves data analysis, reporting, and ensuring compliance with quality standards in the medical device industry, contributing to vital life-changing outcomes.

Benefits

Comprehensive health care programs

Paid time off

Opportunities for career development

Qualifications

• 5+ years in medical device/life science.
• Minimum 2 years in Quality Engineering/QA.
• Experience with ISO 9001:2015 or ISO 13485:2016 is a plus.

Responsibilities

• Lead activities for customer feedback and quality agreements.
• Provide trending analysis on quality issues and metrics.
• Ensure timely execution of field actions and communications.

Skills

Data Analysis

Quality Assurance

Continuous Improvement

Education

Bachelor’s degree in science, engineering, medical, or technical field

Tools

PowerBI

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 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 Senior Quality Assurance Specialist & CDT&R Lead will lead activities for the SCIEX consumables products portfolio relating to customer feedback, manage global Customer Quality Agreements and the implementation of global post market field actions. The incumbent will also engage with other global processes within the Sciex organization.

This position reports to the Director, Customer Quality, and is part of the Quality Assurance & Regulatory Affairs (QARA) department located in Concord, Ontario.

In this role, you will have the opportunity to:

• Provide trending analysis on quality issues and performance metrics. Responsible for reporting quality metrics via the standard monthly report and driving continuous improvement in quality system metrics through sustaining projects.
• Support data analysis & reporting for Management Review.
• Responsible for Quality Agreements, including creating and maintaining agreements, interfacing with internal and external stakeholders, and coordinating customer notifications.
• Ensure field actions are executed in a timely manner and coordinate internal and external communications, reconciliation and reporting.
• Support additional QARA initiatives and/or activities as required.

The essential requirements of the job include

• Bachelor’s degree in science, engineering, medical, or technical field with 5+ years in medical device/life science industry
• Minimum of 2 years of experience with Quality Engineering/Quality Assurance or similar role in a regulated business.
• Ability to interpret complex data sets, generate insightful reports, and present findings to drive strategic decision-making.
• Capable of effectively conveying information and collaborating with diverse teams, ensuring alignment and understanding across various departments.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel internationally, 10%

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

• ISO 9001:2015 or ISO 13485:2016 experience
• Proficiency in PowerBI or similar data analysis tools

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

#LI-LCS

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 [e-mail] to request accommodation.