Location
Markham, ON | Canada
Job description
It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.
At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed, and influenced by our core behaviors:
- Keep customers front and center in all of our work
- Be accountable and deliver on commitments
- Drive continuous improvement
- Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment
Standard BioTools is looking for a Quality Assurance/Regulatory Affairs Associate to support the products’ quality and regulatory activities. The Quality Assurance and Regulatory Affairs associate is responsible for maintaining and ensuring that the company quality system meets requirements for medical devices, and International Directives. The QA/RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international) such as REACH, RoHS, WEEE, CE, etc.
Description
- Maintain Technical Documentation files in compliance with international requirements.
- Oversee the company REACH and Safety Data Sheet program.
- Approval and release of Quality Records, Device History Records, Batch Records Master Labels and Device Master Records.
- Support and administration of risk assessment review process and implementation of changes to risk management process as needed.
- Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions.
- Development of controlled documents and procedures pertinent to Quality Assurance activities and functions.
- Assists with customer complaints/CAPA system.
- Supports new product development, risk analysis, and launch processes, and manage QA participation on new production development.
Minimum Qualifications:
- Bachelor’s degree required, life science / engineering.
- Regulatory Affairs / Quality Management RAC certificate is preferred.
- Experience with ISO 13485, ISO 9001, required.
- Knowledge of and experience with the following standards: IEC 60601-1, ISO 13485, ISO 14971, IEC 62366, IEC 62304, CE-IVDR and 21 CFR 820.
- Knowledge with REACH, RoHS, WEEE, CE mark, UKCA directives and Safety Data Sheet compliance.
- ASQ Certification preferred but not required (such as CQA, CQE, CMQ/OE).
- 1-2 years of industry experience preferred.
- ISO 13485 Internal Auditor certificate a plus.
- Salesforce Experience a plus.
- Basic knowledge of Excel.
- Fast learner, self-starter, accountable, reliable.
- Ability to successfully work in a dynamic environment.
- Able to work under pressure and tight timelines.
- Problem solving attitude.
- Cross-functional perspective and coordination.
The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer.
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