Quality Validation Engineer II

3 weeks ago

Athlone, County Westmeath, Ireland Medtronic Full time

Medtronic
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 

Our Purpose 
At our Manufacturing Facility, we focus on meeting customer and patient needs every day. Our focus is on delivering the highest levels of quality products to our patients. We do this through the development and operation of manufacturing processes to the highest levels of efficiency and performance. We achieve our aims through our people, our high performing teams. We focus on the development of innovative medical devices in Airway Management but also for other life enhancing applications. In this exciting role as Quality Validation Engineer, you will directly support the strategic automation and capacity enhancement program.

Come for a job, stay for a career

A Day in The Life of
Responsibilities may include the following and other duties may be assigned:

• Provide Quality support for new equipment development projects.

• Design/author/review/approve/execute qualification/validation documentation and cycle development studies in line with the standard approval process.

• Risk Management – as part of a team, support the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis. 

• Establishes the quality and compliance requirements for new manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling, fabrication of tools and equipment.

• Resolving technical issues encountered during study execution.

• Engagement with production, maintenance, and quality representatives in the assigned area of operations during execution of cycle development & qualification activities.

• Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance activities.

• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

• Participate in preparing/critically reviewing/approving NCMRs/CAPAs/Investigations and validation activities, providing expert QA technical direction and solutions as appropriate.

• Interacts with internal and external stakeholders in the processing of all quality and compliance activities and documentation ensuring our right-first-time culture prevails.

• Travel required 10-15% of the time for this role.

Key Skills & Experience

• Level 8 Degree in a relevant Quality/Engineering/Science related discipline.

• Preferably with 3+ years relevant experience in a medical devices or similar regulated environment.

• Working Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly, etc.

• Knowledgeable in Quality Systems, validation standards, policies, procedures, and methodologies. 

• Knowledge, understanding and implementation of GAMP5 is an advantage. 

• Experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques.

• A dynamic team- player and problem solver who can work effectively on cross-functional teams.

• Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken.

• Excellent organizational skills and can prioritize and work effectively on multiple projects.

Medtronic offer a competitive salary and flexible Benefits Package

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