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Details

QA Director


Reference:JCA006911 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Director, QA Manager, Quality Director

Our client an expanding early stage company is currently seeking a QA Director to join their team. The QA Director will work alongside current QA/RA Director and take on all the Quality aspects of QA/RA Directors role as focus of current QA/RA Directors moves towards Clinical and Regulatory

Roles/Responsibilities

ISO 13485 Maintenance including but not limited to:
• Management review
• Notified Body/ Competent Authority Audits
• NCR/ CAPA
• Auditing
• Document Control
Day to Day QA Support to Engineering including:
• Supplier Qualification
• Equipment Control including IQOQ PQ and software validation
• Purchasing/ Incoming Inspection/ Stock Control
• DCN review
• DHF maintenance/ organisation and control
QMS update to comply to:
• MDR
• 21 CFR 820
QMS update to facilitate GCP compliant pivotal clinical study
Supplier Control including:
• Supplier audits
• SCARs
• Performance monitoring
• Manufacturing validation
• PFMEAs
• Change of material assessment and control
Sterilisation
• Validations
• Lot release

Skills/Experience

• Minimum 10+ years of relevant experience in medical devices industry with 5 years in leadership roles
• Bachelors in a scientific discipline required with 7-10 years’ experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
• Demonstrated knowledge of FDA regulations, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other national and international regulations and standards.
• Experience with direct contact with FDA and ISO Notified Bodies
• Knowledge of process design and implementation, change control, auditing, and document management systems.
• General knowledge of statistical analysis.
• Demonstrated organizational, management and communication skills.
• Good interpersonal & communication skills essential
• Start-up experience desirable
• Experience working with sub-contract manufacturers/suppliers, including integration of quality management systems is essential
• Behaviours & Skills required include a strong work ethic, combined with creativity, initiative and great technical capability. Excellent presentation and verbal communication skills are essential



James Cassidy | Tel: +353 (0) 1 5079250