Quality Engineer with experience in an electronic design team required by growing space technology company in Dublin

Requirements: 

• Minimum Degree in a Science or Engineering discipline
• 3-5 Years’ experience in a quality role within an electronic design environment
• Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritise is required
• Demonstrate detailed working knowledge of the medical device industry
• Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers and customers
• Self-motivated, flexible with a desire to learn new tasks
• Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives
• Capacity to maintain the highest level of confidentiality internally and externally.
  Excellent MS Office experience (Word, Excel, PowerPoint etc.)
• High level of teamwork and engagement
• Internal/external auditing experience would be an advantage
• Validation experience including Sterilization, process and packaging validations would be beneficial
• Knowledge of Medical Device manufacturing environment including cGMP would be an advantage

Key Responsibilities:

• Provide technical quality support to Project Manager, Design Engineers, Production manager and clients
• Work closely with Engineering team and the client to establish and maintain compliant product specifications
• Quality review of process validation plan, protocols, and reports
• Co-ordinate and contribute to the generation and maintenance of compliant product risk management files
• Issue, review, and release of lot records to manufacturing
• Co-ordinate and review of testing and release of sterilise product
• Quality review of SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures
• Review and approve product change controls
• Liaise with suppliers and clients on quality related issues
• Perform an active role in further development and continuous improvement of the QMS
• Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints
• Perform CAPA reports
• Support clients in product submission to applicable regulatory authorities
• Support Quality Department in implementing and maintaining QMS
• Conduct internal audits and compilation of associated documentation
• Support and assist in the preparation for customer and surveillance audits
• Updates job knowledge by participating in educational opportunities

Please send cv in confidence to emer@emtechrecruitment.ie