Quality Systems Specialist

Danaher; Concord; Sur place; CAD 85 000 - 93 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical/dental/vision insurance

Retirement savings plan

Résumé du poste

SCIEX, a Danaher operating company, is seeking a Quality Assurance professional to maintain and improve the Quality Management System (QMS) in line with ISO 9001, ISO 13485, FDA QMS, and related standards. This on-site role is located in Concord, Ontario, reporting to the Senior Manager, QMS within the QA & Regulatory Affairs Team.

You will support audits, CAPA, document control, training, eQMS administration, quality metrics, and cross-functional improvement projects, with opportunities to

Qualifications

• Minimum three years of quality assurance or QMS experience in regulated development or manufacturing environments 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.

Responsabilités

• Maintain and improve the QMS processes in accordance with regulatory requirements and internal standards.
• Administer eQMS activities including document changes, controlled records, training, reporting, and revisions to QMS procedures and work instructions.
• 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 elevate significant compliance risks to QMS leadership.
• Support non-product software validation and cross-functional QMS improvement projects.

Connaissances

Quality Assurance

QMS

Auditing

Data analysis

Regulatory compliance

Formation

Bachelor's degree in science/engineering/quality assurance

Outils

eQMS software

Power BI

Statistical tools

Description du poste

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 Syste m which makes everything possible.

This position 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 elevate 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.

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,