Quality Engineer (Medical Device)
Life Science Recruitment are sourcing a Quality Engineer for a global Medical Device company based in South Dublin. Reporting to the Senior Quality Engineer, the duties of this position will include management and execution of process validation studies, active participation in non-conformance investigation, process improvement projects, project management, application of SPC to current production processes and liaison with key clients.
Roles & Responsibilities
• Development and optimisation of control plans.
• Ensuring design transfer activities are carried out such that all product design requirements are satisfied in a controlled manner through to shop floor introduction.
• Key team member for process development & cross-functional teams to ensure that process development is carried out using the correct statistical methods and to provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems.
• Ensuring adherence to all organisational and external regulatory requirements.
• Participating as an active member of the site internal audit team, liaising with regulatory auditors.
• Supporting production personnel in relevant continuous improvement activities (Six Sigma etc.) and act as customer liaison contact for given key customers as appropriate.
• Assist in the review, analysis and reports of relevant customer complaints.
• Drive cGMP practices within Operations and Quality divisions.
• Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements.
Skills & Qualities
• The successful candidate will have a minimum of 3-5 years work experience in an ISO 9001/2000 or ISO 13485 environment, preferably coupled with a background in Medical Devices/Pharmaceutical Industry.
• A primary degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
• Experience of preparing technical documentation with a good knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
• Experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits.
• Experience of working in process validation and a clean room environment.
• Experience of working within a cross-functional team and have excellent interpersonal and communication skills coupled with a high level of computer literacy. You will interact with all levels of colleagues and bring cross-functional team working to its fullest potential.
You can look forward to a rewarding career, great benefits package, collaborative working and internal opportunities that will expand your skillset in a fast-moving, dynamic and agile business.
If you would like further Information you can contact the recruiter directly:
Simon Gillivan | Tel: +353 (0) 1 507 9258 M: +353 87 360 3933