Senior 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
- 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:
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Internal/external auditing experience
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Validation experience including Sterilization, process and packaging validations
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Knowledge of Medical Device manufacturing environment including cGMP
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Understand general principles of ISO 14971
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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:
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Assist with the development and maintenance of quality evaluation and control plans and protocols for processing materials into finished products
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Assist with the confirmation that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements
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Issue of Product paperwork/batch records to manufacture and also review and release of same and compile COA/COC
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Approval of change requests for product, process and quality changes
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Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects and change notices
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Preparing and updating Operations procedures and associated documentation
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Quality review of responsible area validation documentation
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Performing an active role in further development and continuous improvement of the QMS
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Liaise with suppliers and customers on quality related issues
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Assist Head of Quality in implementing and maintaining the QMS
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Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions
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Create, maintain and issue company quality documentation, such as SOP’s, and WI’s
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Support customer and surveillance accredited audits
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Drive continuous improvement and best practices in QMS “Right First Time”
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Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations
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Updates job knowledge by participating in educational opportunities
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Ensure compliance to all applicable regulatory standards and cGMP procedures and practices
emer@emtechrecruitment.ie
