Quality Engineer, Medical Devices

Quality Engineer, Medical Devices, Galway Hub, contracted manufacturing services to international medical device clients

We are currently looking for an experienced Quality Engineer to join a close-knit team of Engineers at their Medical Device contract services company in the Medical Device hub that is Galway, Ireland. This role will afford you responsibility to work with the Quality team ensuring compliance across the site. Having previous experience of working within a medical device manufacturing environment is ideal.

On offer here is also a great deal of flexibility in relation to working from home options, flexible hours and autonomy allowing you to maintain a solid work-life balance. You also will get to work for a company that has multinational blue-chip medical device clients from across world using its services. There is also potential to progress within the Quality department or into another department as the company expands.

Responsibilities:

• Inspecting and testing materials, equipment, processes and products to meet quality specifications
• Investigating and troubleshooting product or production issue
• Developing corrective actions, solutions, and improvements
• Managing non-conformance including CAPA processes
• Collaborating with Operations and Quality teams to develop and implement controls and improvement
• Creating and monitoring supplier evaluation and audit programmes and schedule
• Full involvement in internal and external audits and risk assessments, taking corrective actions if require
• Working with the Quality & Regulatory Manager to implement Product Quality practices and procedures compliant with relevant standards (including ISO13485:2016)

Requirements:

• Working in a highly regulated industry with a process driven environment
• Working within a regulated product production industry (ISO9001 or ISO13485 preferred)
• Thorough understanding of Quality Management Systems (ideally within an ISO13485 environment)
• Lean six sigma qualification ideal but not essential

For a confidential discussion please get in touch with Blaine McKeever by clicking apply.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.