Full Job Description
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.
In this role, you will have the opportunity to:
• 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.
The essential requirements of the job include:
• 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.
It would be a plus if you also possess previous experience in:
• Non-product software validation and AI applications.
• Power BI, and data-analysis or statistical tools.
• Internal auditor or lead auditor training.
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.
The annual salary range for this role is $85,167 - $93,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits 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.
