3040 QA/RA Specialist

Hess Associates

  • Vaughan, ON
  • Permanent
  • Temps-plein
  • Il y a 20 jours
Vaughan, Ontario (On-Site) | Reports to QA/RA Manager | Full-TimeOur client is a fast-growing health supplements and PPE manufacturer and distributor seeking a hands-on Quality Assurance/Regulatory Affairs Specialist to work on initiatives related to compliance, quality, and regulatory affairs. Reports to the Quality Assurance / Regulatory Affairs Manager.What You’ll DoWork on regulatory submissions (Health Canada, NSF, FDA) and product/site licensing.Help the Manager develop & maintain SOPs and monitor regulatory compliance.Participate in planning and executing internal/external audits and CAPA programs.Partner with R&D, Manufacturing, and Supply Chain to help the Manager embed compliance in daily operations.Monitor regulatory changes and update processes accordingly.Help Build the QMS from the ground up as required.What You Bring3+ years in combined QA/RA roles in natural health products, nutraceuticals, food manufacturing, PPE, medical devices, or pharmaceuticals.Proven success in contributing to regulatory submissions to Health Canada, NSF, or FDA.Background in GMP, NSF standards, and QMS implementation.Bonus: Familiarity with ISO 13485 and/or Health Canada Medical Device Regulations.Strong English communication, problem-solving, and team player skills. * Able to work on site.Why Join Them?Making a contribution with visible results.Career growth to QA/RA Manager.Collaborative and entrepreneurial environment.Competitive salary and benefits.

Hess Associates