Job Description
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.
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 teamsDevelopment of workflows for eDMSMedical device vigilance / reporting assessment, initial triage and oversightCompletion of regular metrics and data reporting to managementNC, CAPA & Complaint assessment, use of root cause tools, and trending analysisProduct registration supportPlan, develop, execute and maintain internal audit schedule for Ennis.Conduct internal audits across business functions, providing meaningful challenges to the documentedprocesses 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 newschemes 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 andemerging 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 suchother duties as assigned by the Quality Manager / EVP Manufacturing Operations. Such duties can be outside
the normal area (and hours) of work.
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 packagesGood command of written English needed for audit reports and record closure.Willingness to travel to other Vitalograph sites as necessary.Key Competencies :
Must be highly motivated and have a strong desire to succeed in a demanding role.Sees the big picture, understands key business drivers, anticipates challenges, navigates ambiguity and complexity.Outstanding organisational and time-management skills.Ability to positively influence thinking, behaviour, and gain commitment.Exceptional ability to leverage / collaborate effectively with internal stakeholders.Excellent written and verbal communication and interpersonal skills.Strong problem-solver.Secures resources and builds the team, system and culture needed to meet commitments and drive results, balances short and long term needs and goals, and effectively leads change.