Senior Quality Assurance Engineer - North Dublin, medical devices sector.

Our client is seeking an enthusiastic and self-motivated Senior Quality Engineer whose main role will be to support the Regulatory and Corporate Quality team in maintaining the company's Quality Management System in accordance with ISO 13485, FDA CFR 21 Part 820 and GMP.
 
The key outputs and deliverables (the duties) of the role will be:
 
• Ensuring compliance with national and international standards and legislations.
• Maintenance of Quality Management System procedures and processes.
• Leading internal, customer and supplier audits.
• Act as the Local Quality Representative for the manufacturing site to the Medical Products Group.
• Customer complaints / vigilance.
• CAPA.
• Quality control and quality assurance for products manufactured on site.
• Developing validation plans and protocols encompassing design, process and equipment.
• Working with project teams in the development of risk analysis documentation.
• Product transfers.
• Ability to implement quality improvement programmes.

 
Interested applicants should be and have:

• Educated to at least degree level in an appropriate technical discipline.
• Minimum of 5 years' experience in a quality role in a medical device manufacturing environment.
• Previous experience of conducting risk management activities.
• Experience in control of terminally sterile product.
• Validation experience.
• Working knowledge of FDA QSR and ISO 13485.
• Trained auditor.
• Experience in use of statistical techniques.

 
Desirably (not essentially) you will also have:
 
• Microbiology qualification.
• Project Management experience.
• Strong problem solving skills; 6 Sigma, etc.

Person specification:
The applicant must also possess strong interpersonal and organisation skills and should be able to demonstrate a strong understanding of GMP.

Based at the North Dublin plant, the role may also involve regular travel to the UK HQ for future product development.