Quality Assurance Specialist

4 weeks ago


Somerset, United States Terumo Medical Corporation Full time
Job Summary

The Quality Compliance Engineer II is responsible for ensuring the compliance of TMC's products and processes in the changing regulatory landscape.

Key Responsibilities
  • Support the management of Health Hazard Evaluations and track EU MDR deliverables
  • Support cross-functional project teams with compliance-related decisions and interpretations
  • Evaluate the impact of standard and regulation updates on existing product families and QMS processes
  • Lead the evaluation of new and revised standards and regulations for impact to products and QMS processes
  • Support the TMC health hazard and recall process
  • Coordinate the HHE process by engaging stakeholders to ensure timely completion
  • Support the drafting, planning, execution, and gathering of information for the Critical Action Committee meeting
  • Execute the recall process by drafting regulatory submission documents and coordinating reviews
  • Support cross-functional projects as a compliance SME
  • Act as an independent reviewer on design control projects to ensure compliance with internal procedures and external standards and regulations
  • Provide quality system and product guidance on updated regulations and standards
  • Maintain expertise in quality management standards, software, and tools applicable to Terumo Medical Corporation
Requirements
  • B.S. degree or equivalent in Engineering or Scientific discipline required or relevant experience with equivalent combination of education and experience
  • 3-5 years' overall experience required with at least 3 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on product or production, or quality-related responsibilities preferred
Knowledge, Skills, and Abilities
  • Familiarity with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements
  • Ability to identify and recognize how the standards and regulations potentially affect the wider business of the company
  • Ability to use process development tools such as Lean Six Sigma
  • Ability to apply a practical level of statistics and develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports
  • Strong proofreading and writing skills, as well as exemplary attention to detail
  • Strong organizational and prioritization skills
  • Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company
  • Technical knowledge to be able to summarize and distill complex information
  • Demonstrated initiative and ability to work independently while handling multiple tasks
  • Strong computer knowledge (MS Office), technical writing skills, and proofreading ability
  • Demonstrated ability to work effectively with cross-functional teams for problem-solving, product, and process improvement


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