Medical Devices
Medical Devices

Senior Principal Auditor

Belgium, Zaventem

Scope

Fantastic opportunity to join a global manufacturer of innovative market leading medical devices, an organisation that have been at the forefront of the coronavirus pandemic and continue to grow their teams at a rapid rate. This successful candidate will offer the opportunity to consult and advise the wider organisation and work in an international team across EMEA & UK.

Responsibilities

The Senior Principal Auditor will assist in the definition and implementation of the Internal Audit Program. Responsible to assess compliance and the effectiveness of the Company Quality System against global internal and external regulatory requirements, policies, and procedures as applicable. Monitors internal audit schedule. Responsible to monitor and analyze regulatory agency and notified body trends and understand implications and direction of regulatory changes.

  • Develops, manages, and mentors other auditors.
  • Responsible for collecting, interpreting, and applying regulations to maintain an effective QMS.
  • Responsible for documenting, scheduling, planning, conducting, and reporting internal audits of site’s quality management system activities to assure compliance with applicable global regulatory requirements, global policies, and procedures.
  • Responsible for management of Audit Teams.
  • Responsible for managing projects and dealing with obstacles and changes while still accomplishing goals and objectives. Uses project management skills to conduct audits. Mentors Auditors in project management.
  • Identifies, accesses, and analyzes all the internal and external data streams that have impact on the company's compliance to overall quality systems. Integrates data into our quality systems to create a clear, current, and accurate state of compliance. Strategically leverages information to assist in design of a robust global audit program. Charts data and makes recommendations based on areas of highest compliance risk.
  • Connects well globally to understand changes in regulatory environment worldwide as it relates to the quality systems and adjust audit plans and approach accordingly. Identifies audit trends and anticipates future audit focus.
  • Responsible for timely completion of all corrective actions and nonconformance’s related their areas of responsibility.

About You

  • 8-10 years of quality systems and GMP experience in the medical device, pharmaceuticals, or comparable environment
  • Achieved recognized auditor certification from IRCA, RABQSA, or other government body
  • Bachelor's degree in Life Sciences, Engineering, Medical or related field
  • Lead auditor certification
  • ISO13485:2016 training
  • Training in IVDR or MDR, and 5 or more additional regulations
  • Extensive knowledge of the FDA Code of Federal Regulations (21 CFR 820), applicable ISO standards (e.g., ISO 13485:2016, ISO 14971), MDSAP, MDR and/or IVDR, and other key relevant global regulations. Excellent verbal / written communication, interpersonal, and organizational skills; must be able to multi-task, assimilate, and analyze information quickly.
  • Computer skills required are MS Word, Excel, MS Outlook, Agile, and general database experience.
If you are interested in the above role then please apply or get in touch to discuss further.
Elliott Firth Managed by Elliott Firth
highlights
International
Permanent
Technical
apply Posted - 11.02.2021

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Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.