ABOUT VITALOGRAPH

Vitalograph is the world’s leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. We design and manufacture respiratory diagnostic devices, software, and consumables for healthcare professionals, for almost 60 years, and serve customers in over 100 countries. Headquartered in the UK, Vitalograph has operations in Ireland, Germany and the USA.

KEY SKILLS AND QUALIFICATIONS:

• 3rd level qualification in a science or engineering discipline.
• Good project planning and organizational abilities.
• Assertive, with strong interpersonal and communications skills.
• Pro-active with proven ability to work under own initiative, while being a strong team player.
• Excellent skills with word, excel and other MS suite packages
• Good command of written English needed for audit reports and record closure.
• Willingness to travel to other Vitalograph sites as necessary.

processes and evidence presented in support of same, against requirements of multiple regulations.

• Develop audit scope and methodology in line with QMS and PMS findings, and the requirements of ne

THE ROLE:

Reporting to the Quality Manager, the Graduate Quality Engineer provides Quality Engineering support and direction to Operations and the QMS.

• Participate in wider team meetings to enable fulfilment of company’s sales order plan.
• Ensure that all work and tasks carried out are consistent and compliant with our QA/RA systems including but not limited to:
• Procedure Adherence: All procedures are adhered to consistently.
• NC/CA: NC & CAs are dealt with in a timely manner, within requirement

KEY RESPONSIBILITIES:

• Quality Engineering support and mentoring for Operations and R&D teams
• Development of workflows for eDMS
• Medical device vigilance / reporting assessment, initial triage and oversight
• Completion of regular metrics and data reporting to management
• NC, CAPA & Complaint assessment, use of root cause tools, and trending analysis
• Product registration support
• Plan, develop, execute and maintain internal audit schedule for Ennis.
• Conduct internal audits across business functions, providing meaningful challenges to the documented

processes and evidence presented in support of same, against requirements of multiple regulations.

• Develop audit scope and methodology in line with QMS and PMS findings, and the requirements of new

schemes or regulations, such as MDSAP and MDR, etc.

• Provide investigation of Customer Complaints, CAPAs and NCs, assimilate and collate data to assure truthful,

accurate and compliant authoring of data associated with these records, and drive them to timely closure

within eDMS.

• Support Supplier Quality Engineer activities as needed.
• Support RA QA team in QMS updates, creating or revising SOPs, Form templates etc, to align with new and

emerging regulations or associated customer/sponsor and market expectations, to ensure robustness and

currency of overall audit process.

• Provide regular reports to Snr management.
• Flexibility is a requirement of this position, and the successful candidate must be prepared to undertake such

other duties as assigned by the Quality Manager / EVP Manufacturing Operations. Such duties can be outside
the normal area (and hours) of work.