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. Headquartered in the UK, Vitalograph has operations in Ireland, Germany and the USA. Our mission is to improve patient lives by designing and manufacturing market leading products and services.

KEY REQUIREMENTS:

• 3rd level qualification, or equivalent including experience, in a science or engineering discipline.
• At least 5 years’ experience in medical device manufacturing within a QA role, using ISO 13485, CE Marking and FDA QSRs
• At least 3 years’ experience with medical device vigilance process and demonstrable understanding of risk
• Previous experience in a QC or QA, or Internal auditor role within medical device manufacturer.
• Certification as an auditor - Vitalograph will cover costs of the course.
• 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.

KEY SKILLS:

• 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.
• Uses good judgement and can make effective decisions on complex issues despite short timelines and pressure.
• Self-disciplined, organised and can take ownership and responsibility for business objectives.
• Independent, critical thinker with strong decision-making skills.
• Ability to positively influence thinking, behaviour, and gain commitment.
• Hungry for new information and development; self-aware and has an urgent sense for continuous improvement.
• Exceptional ability to leverage/collaborate effectively with internal stakeholders.
• Excellent written and verbal communication and interpersonal skills.
  Job Type: Full-time
  Work Location: In perso

THE ROLE:

Reporting to the Quality Manager, the Quality Engineer is responsible for offering support and direction to Operations and the QMS. You will partner with the wider team, working to tight deadlines in a dynamic operating environment!

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
• Drafting of SOPs and associated documentation for QMS
• Completion of timely record and metric related transactions
• Completion of regular metrics and data reporting to management
• NC, CAPA & Complaint assessment, use of root cause tools, and trending analysis
• Contribute to Continuous Improvement initiatives
• Product registration support
• Perform other duties as may be assigned in support of compliance or QMS activities.