QUALITY ENGINEER
​We are a specialist agency providing design & development of medical devices. We work alongside leading clinicians, pharma and med-tech providers to develop ground breaking new healthcare solutions. With major projects ongoing, and demand increasing, we are looking for new people to join the team.
LOCATION
Glasgow/ Hybrid
EMPLOYMENT TYPE
Permanent
Aspects Of The Role
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Perform quality, design control, risk management and usability engineering activities, according to Fearsome’s quality management system, across a range of medical device development projects
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Establish quality control measures, including inspection techniques, sampling procedures, and testing protocols
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Maintain comprehensive documentation of quality processes, procedures, and records, ensuring accuracy and traceability
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Support the creation of regulatory submission documentation
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Cross-functional collaboration with R&D design teams, manufacturing, regulatory & quality, to ensure quality objectives are met throughout the product lifecycle
Required Skills:
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Bachelor’s degree or equivalent in engineering or other technical/scientific area
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Proven experience (2+ years) in quality engineering or a related role in the medical device industry
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Strong understanding of regulations and standards affecting medical device development, in particular; ISO 13485, MDR 2017/745, 21 CFR 820, ISO 14971 and IEC 62366-1
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Familiarity with design control, risk management and usability engineering principles and experience in participating in design reviews
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Solid understanding of manufacturing processes, quality control methods, and statistical principles and techniques
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Excellent analytical, problem-solving, and decision-making abilities with strong attention to detail
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Excellent communication skills, both written and verbal, with the ability to effectively communicate with cross-functional teams