Quality Systems Engineer II

4 weeks ago

Reston, Virginia, United States Terumo Medical Corporation Full time

Job Summary:

The Quality Systems Engineer II at Terumo Medical Corporation drives the Corporate CAPA Program to ensure it is compliant with applicable global Quality System regulations, effective, and efficient in dealing with quality issues.

Key Responsibilities:

  • Support the management and effectiveness of the Quality Management System, primarily the CAPA system by:
  • Establishing and maintaining CAPA process metrics
  • Providing guidance to CAPA Teams
  • Participating on CAPA Teams as needed
  • Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements
  • Approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification
  • Teaching and mentoring CAPA owners on root cause analysis and technical writing
  • Organizing the Stewardship reviews of CAPA documentation
  • Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner.
  • Facilitating activities related to the CAPA Board Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood and appropriately incorporated into CAPA documentation and Management Review
  • Generating Quality System Standard Operating Procedures as required.
  • Contributing to the development of Quality System training materials and delivering training where applicable.
  • Contributing to the development of Quality System performance measures.
  • Supporting FDA & third-party audits as required.
  • Following all established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
  • Performing other duties as assigned.

Requirements:

Knowledge, Skills, and Abilities (KSAs)

  • Knowledge in 21 CFR Part 820, ISO 13485:2016, Medical Device Directive / Regulation.
  • Strong computer knowledge (MS Office), technical writing skills, and proofreading ability.
  • Ability to develop, communicate, and support the interpretation and implementation of comprehensive quality systems/regulatory requirements.
  • Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports.
  • Demonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectiveness.
  • Demonstrated ability to interact with all levels of management, co-workers, and regulators.
  • Strong decision-making and prioritization skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Strong organizational and presentation skills.

Background Experience:

  • Position requires a 4-year degree in engineering or a scientific discipline or equivalent work experience.
  • Minimum 2 years' experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical company.
  • Experience performing root cause analysis/investigations.
  • Experience supporting a regulated manufacturing operation.
  • Experience with electronic quality system tools.
  • Six Sigma Black/Green Belt Certification a plus.
  • ISO 13485 Lead Auditor Certification a plus.

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