Senior Quality Systems Engineer

1 day ago

Elkton, Minnesota, United States Terumo Full time

Job Title: Senior Quality Systems Engineer

Job Summary:

The Senior Quality Systems Engineer will drive Terumo's efforts to ensure compliance with applicable global Quality System regulations in an efficient manner.

Key Responsibilities:

  • Support the management and effectiveness of the Quality Management System, primarily the CAPA system
  • Provide guidance to CAPA Teams and participate on CAPA Teams as needed
  • Review content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements
  • Approve corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification
  • Teach and mentor CAPA owners on root cause analysis and technical writing
  • Organize the Stewardship reviews of CAPA documentation
  • Manage the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner
  • Establish and maintain CAPA process metrics
  • Lead activities related to the CAPA Board and work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood and appropriately incorporated into CAPA documentation and Management Review
  • Generate Quality System Standard Operating Procedures
  • Develop Quality System training materials and deliver training where applicable
  • Contribute to the development of Quality System performance measures
  • Lead third-party audit activities as required

Requirements:

  • Demonstrated knowledge in 21 CFR Part 820, ISO 13485:2016, Medical Device Directive/Regulation
  • Strong computer knowledge (MS Office), technical writing skills, and proofreading ability
  • Strong 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
  • Must possess strong decision-making and prioritization skills
  • Must possess strong written, verbal, and interpersonal communication skills

Preferred Qualifications:

  • Position requires a 4-year degree in engineering or a scientific discipline or equivalent combination of education and work experience
  • Minimum 8 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 preferred
  • ISO 13485 Lead Auditor Certification preferred

Terumo's Commitment to Diversity and Inclusion:

Terumo is an equal opportunity employer and prohibits discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination, or any other terms and conditions of employment.

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