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Quality Assurance Associate

2 months ago

Markham, Ontario, Canada fluidigm Full time
Job Description

At Standard BioTools, we are seeking a highly skilled Quality Assurance/Regulatory Affairs Associate to support our products' quality and regulatory activities.

Key Responsibilities:
  • Maintain and ensure that the company quality system meets requirements for medical devices and international directives.
  • Ensure that products and their labeling meet all regulatory requirements, including REACH, RoHS, WEEE, CE, and others.
  • 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.
  • Assist with customer complaints/CAPA system.
  • Support new product development, risk analysis, and launch processes, and manage QA participation on new production development.
Requirements:
  • Bachelor's degree in life science or 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, 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.