Quality Compliance Engineer II

Job Summary

The Quality Compliance Engineer II is responsible for maintaining the compliance of TMCs products and processes in the changing regulatory landscape. Specifically, the individual will be responsible for supporting the management of Health Hazard Evaluations, tracking of EU MDR deliverables, supporting cross-functional project team with compliance related decisions/interpretations, and evaluating impact of standard/regulation updates to existing product families and QMS processes.

Job Details/Responsibilities

• Support standards/regulation program by leading the evaluation of new and revised standards/regulations for impact to products and QMS processes
• Support the TMC health hazard and recall process.
• Coordinate the HHE process by engaging the stakeholders (ex: Medical, PMS) to ensure the HHE is completed in a timely manner.
• Support the drafting, planning, execution, and gathering of information for the Critical Action Committee meeting.
• Execute the recall process by drafting regulatory submission documents, coordinating reviews of recall documentation, working with affiliates and recall service providers to execute the recall.
• Support cross-functional projects (New Product Development, Sustaining, Acquisition, etc.…) as a compliance SME
• Act as 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/standards.
• Maintain expertise in quality management standards, software, and tools applicable to Terumo Medical Corporation
• Good documentation practices, ISO 13485, GDP, validation, and verification/qualification.
• Develop and maintain expertise in applicable quality regulations, including, but not limited to:
• U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) for Medical Devices (21 CFR 820).
• Health Canada cGMP,
• European MDD and MDR
• Provide ongoing reinforcement of compliance and quality culture.
• Drive Quality System or product enhancement projects associated with regulatory changes.
• Review and draft proposals to implement changes to the Quality System procedures/forms as needed to maintain compliance, improve effectiveness and efficiency.
• Assist and/or conduct internal audits to assess compliance with applicable regulations and standards (e.g. - Quality System Regulation (QSR), ISO 13485, ISO 14971, ISO 11607, ISO 11135/ EN550, ISO 11137/ EN552 and the amended Medical Device Directive).
• Assist with third party/regulatory audits (Customer, Notified Body, FDA)
• Performs other job-related duties as assigned.

Knowledge, Skills and Abilities (KSA)

Quality and business process knowledge:

• Familiarity with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements.
• Ability to identify and recognize how the standards & regulations potentially affect the wider business of the company
• Ability to use process development tools (ex. Lean Six Sigma)
• Ability to apply a practical level of statistics. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports

Leadership skills:

• Demonstrated ability to communicate and interact with all levels of the organization including management
• Strong interpersonal skills to provide coaching, training, and direction

Individual skills required:

• 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 is required.

Qualifications/ Background Experiences

• 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