Quality Assurance Officer (F/M) (Vaughan)

Quality Assurance Officer (F/M) (Vaughan)

30 Oct
|
SCIEX
|
Vaughan

30 Oct

SCIEX

Vaughan

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.

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 Systems Specialist supports the maintenance and continuous improvement of the SCIEX Quality Management System in accordance with ISO 9001, ISO 13485, FDA Quality Management System Regulation, and other applicable requirements. This role supports audits, CAPA, document control, training, eQMS administration, quality metrics, and continuous improvement. The position works cross-functionally to strengthen compliance, process effectiveness, and inspection readiness.

This position reports to the Senior Manager, QMS, and is part of the Quality Assurance & Regulatory Affairs Team located in Concord, Ontario and will be an on-site role.





Support the maintenance and improvement of QMS processes in accordance with applicable regulatory and internal requirements, including supporting internal and external audit planning, readiness, execution, responses, and action-item closure.

Administer eQMS activities, including document changes, controlled records, training assignments, reporting, revising QMS procedures, work instructions, forms, and training materials.

Guide audit NC owners and CAPA owners through investigations, action planning, implementation, documentation, and effectiveness verification.

Monitor quality metrics, analyze trends, maintain dashboards, identify improvement opportunities and escalate significant compliance risks to QMS leadership.

Support non-product software validation and cross-functional QMS improvement projects.

Bachelor’s degree in science, engineering, quality assurance, or a related field, or equivalent education and experience.

Minimum three years of quality assurance or QMS experience in a regulated development or manufacturing environment such as IVDs, clinical or pharmaceuticals.

Working knowledge of ISO 9001, ISO 13485, and FDA quality-system requirements.

Experience supporting QMS audits, CAPA, document control, and quality records.





Experience with eQMS applications, procedure writing, and quality-data reporting.

Non-product software validation and AI applications.

Power BI, and data-analysis or statistical tools.

Internal auditor or lead auditor training.

Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and retirement savings plans for eligible employees.

The amount and availability of any bonus, commission, benefits, or any other form of compensation and perks that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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.

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 will ensure that individuals with disabilities are provided reasonable accommodation to access our website, and as applicable participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

📌 Quality Assurance Officer (F/M) (Vaughan)
🏢 SCIEX
📍 Vaughan

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