Quality Engineer with medical devices experience required by growing medical devices company in Galway. Joining a multi-site team serving global markets, you will be responsible for quality engineering activities for manufacturing processes, materials, and products as well as within Project Teams.
Requirements:
- Bachelor’s Degree in a relevant Engineering or Science field
- 1-3 years’ Quality Engineering experience
- Good understanding of ISO 13485:2003, 2012 and FDA QSR
- Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner
- Ability to work on own initiative
- Strong team member with the ability to identify and drive implementation of innovative quality improvements
- Ability to consistently meet deadlines
- Demonstrate and actively promote high levels of professional quality engineering
- Good communication skills
- Ability to write clear, concise technical protocols and reports
- Good administrative/organizational ability with high level of attention to detail
Key Responsibilities:
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Quality Engineering support of manufacturing process including Investigation of root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s in addition to addressing ongoing compliance
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Works with team of Quality Inspectors to ensure all work priorities are properly planned, assigned and adjusted if needed to meet daily, weekly, monthly customer sales order requirements
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Supports Quality reporting metrics; provides data for tracking metrics. Assists in development of root-cause analysis and ensures corrective/ preventive actions are implemented to address non-conformances
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Initiation and support of continual improvement solutions for new and enhanced methods for inspection, testing, and evaluation of data throughout processes
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Work with relevant Engineering Teams to establish inspection plans, frequencies and test methods for incoming material/parts
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Overall responsibility for GMP standards and compliance within the manufacturing area
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Manage assigned aspects of the quality system in compliance with ISO 13485, FDA QSR, MHLW and Canadian Quality System requirements
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Support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary
emer@emtechrecruitment.ie
