Permanent
Quality Engineer
Inchinnan

Senior Compliance Engineer Global

Ref: 64| Posted: 21st Nov 2022

Terumo Aortic are currently recruiting for a Senior Quality Compliance Engineer Global, this is a new role which is to support key processes to ensure our continued compliance between our Glasgow and Florida sites.

The main objectives of the role are;

  • Management and coordination of external regulatory requirements including those cascaded from Terumo Corporate such as Terumo Global Quality Policies (TGQPs), Shoki Ryudo requirements, Quality Assurance Library (QAL) and Successful Quality Practice Guides (SQPGs)
  • Management of site audit readiness for regulatory external inspections.
  • Maintenance of up-to-date cGMP/GDP training materials and delivery of quality management system training including FDA preparation and related requirements
  • Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards including the EU Medical Device Regulation (MDR); ISO 13485, 21 CFR Part 820, MDSAP requirements and other regulations as appropriate
  • Promote a culture of high performance, continuous improvement and regulatory compliance with a commitment to quality.
  • Provide consultation and advice on quality related subjects, supporting business and department objectives whilst ensuring regulatory compliance
  • Works towards meeting departmental and facility objectives. Works towards meeting quality objectives, as stated in quality system
  • Leading advanced preparation of all audits
  • Developing a process for managing of unannounced audits
  • Responding to any identified findings from regulatory audits
  • Following up on audit findings and tracking through to completion
  • Ensuring site audit readiness at all times

The successful candidate will possess;

  • Relevant Science/Engineering Degree or similar
  • Proven experience in Quality Management Systems in a similar role within a medical device or a similar regulated environment
  • Lead or Internal auditor qualified with proven audit experience
  • Strong analytical and problem-solving skills
  • Knowledge and experience of FDA regulations
  • Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
  • Excellent facilitation, coordination, prioritization, presentation and communication skills
  • Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
  • Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department
  • Ability to work across multiple facilities globally to ensure seamless compliance including when significant changes are being introduced