Process Engineer – Subject Matter Expert – with ISO 13485 experience required for key role with growing medical devices company in Galway. As Subject Matter Expert, you will provide expertise on medical process technologies & report on yield, OEE metrics & product failure investigations. Based out of the Shannon site, you will also be required to manufacturing sites in Galway city.
Requirements:
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Degree in Engineering, Technology or Science or an equivalent qualification
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4 years’ experience within ISO13485 registered medical device industry
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Excellent understanding of EN ISO 13485:2016, MDSAP and FDA requirements
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Ability to lead Project Teams and proactively contribute to continuous improvement initiatives
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Ability to create, plan and coordinate changes to product and process with cross functional teams, vendors and customers
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Self-starter with ability to work independently under pressure and react quickly to changing priorities
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Strong team member with the ability to identify and drive implementation of innovative quality improvements
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Meticulous attention to detail while also conveying a sense of urgency
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Effective communication and interpersonal skills; written, verbal and presentation. Must have the ability to communicate effectively and concisely at all levels of the company
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Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner
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Strong Problem-Solving capability, possessing a demonstrated capacity to identify problem root causes, deliver solutions, risk assess
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Data analysis and numeric skills with the ability to evaluate, analyse and present data
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Proficiency in Microsoft Office software
Key Responsibilities:
- Provide subject matter expertise on process technologies to support key business metrics
- Responsible for reporting on yield, OEE metrics and product failure investigation
- Support the introduction of new products and process technology through Process Development and Validation
- Use Lean methodologies to drive continuous improvement focused on Quality, Cost, Material flow and layout
- Lead or actively participate in cross-functional teams to ensure that continuous improvement projects are completed in a timely and efficient manner
- Preparation and maintenance of manufacturing specifications for specific projects
- Ensure effective closure on Quality System documents (Audit Actions, NC’s, CAPA’s, etc..)
- Ensure all production equipment, processes and work areas meet Health & Safety requirements through the completion of the required documentation
- Partners with all customer, FDA and NSAI audits when required
- Assists, as necessary, other functions to achieve timely product shipments
Please send cv in confidence to emer@emtechrecruitment.ie
