Quality Engineer – Medical Devices – with excellent understanding of ISO 13485 and FDA QS regulations required by growing medical devices client in Sligo.

Requirements:

  • Minimum Degree in a Science or Engineering discipline
  • 3-5 Years’ experience working in a medical device environment in a Quality role
  • Strong knowledge of ISO 13485, FDA regulations 21CFR 820
  • Good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, suppliers and customers
  • Desire to learn new tasks and flexibility
  • Attention to detail while maintaining awareness of longer-term objectives
  • Capacity to maintain the highest level of confidentiality internally and externally
  • MS Office experience (Word, Excel, PowerPoint etc.)
  • High level of teamwork and engagement, while at the same time being able to work on their own initiative
  • Strong numerical and problem-solving ability

Desirable:

  • Internal/external auditing experience

  • Validation experience including Sterilization, process and packaging validations 

  • Knowledge of Medical Device manufacturing environment including cGMP

  • Understand general principles of ISO 14971

  • Decision making ability coupled with the ability to work on own initiative and with minimum supervision is required, and ability to multitask and prioritise

Responsibilities:

  • Assist with the development and maintenance of quality evaluation and control plans and protocols for processing materials into finished products

  • Assist with the confirmation that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements

  • Issue of Product paperwork/batch records to manufacture and also review and release of same and compile COA/COC

  • Approval of change requests for product, process and quality changes

  • Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects and change notices

  • Preparing and updating Operations procedures and associated documentation

  • Quality review of responsible area validation documentation

  • Performing an active role in further development and continuous improvement of the QMS

  • Liaise with suppliers and customers on quality related issues

  • Assist Head of Quality in implementing and maintaining the QMS

  • Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions

  • Create, maintain and issue company quality documentation, such as SOP’s, and WI’s

  • Support customer and surveillance accredited audits

  • Drive continuous improvement and best practices in QMS “Right First Time”

  • Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations

  • Updates job knowledge by participating in educational opportunities

  • Ensure compliance to all applicable regulatory standards and cGMP procedures and practices

emer@emtechrecruitment.ie 

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