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Job ID: JOB-13621

Senior Design Assurance – Quality Engineer 

Working in Design Assurance is in big demand right now.  We’re looking to speak with experienced Design Assurance Engineers who are looking to work with top global leaders who value their people.  This is a great job opportunity in Limerick for a Design Assurance Engineer who enjoys working on innovative projects, values autonomy in their job and  working in a great team.

As Design assurance QE you will be involved in new product development and product sustaining projects through the application of Quality engineering skills. You will handle multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.

You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both company and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements.

Main responsibilities will include:

• Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed for the project.

• Write project quality plans and support the creation and maintenance of DHF documentation
• Lead risk management activities within the project.
• Support the creation and implementation of verification and validation activities
• Review and approve test protocol and reports.
• Review and challenge statistical rationale, and data analysis in the frame of test protocol and reports.
• Review and approve related execution deviations.
• Assist / conduct Failure investigations and problem-solving sessions
• Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
• Conduct quality functional reviews and DHF compliance reviews.
• Ensure compliance across projects for design control, risk management, and change control processes.
• MDR specific needs:
• • Ensure state of the art requirements are correctly applied
  • Ensure design controls standards are applied within the program (DDP/QP, Phase-gate etc.)
  • Collaborate with stakeholders (in/out of MDR) to ensure appropriate MDR decisions are made  
  • Create MDR compliant risk files ensuring file is up to date with state of the art standards
  • Support DHF evidence review as required
• Support Quality culture within R&D organisation while providing training on applicable requirements / standards.

About you

• A relevant degree (engineering degree- preferred) or equivalence of minimum 3 years of quality engineering experience
• Knowledge in working with ISO 13485, QSR, ISO 14971, statistical techniques
• Strong written and verbal communication skills
• Strong organisational skills
• Experience with MDR – advantage
• Experience with IEC 62304 and IEC 62366 – advantage

For further information on this role in Galway please contact Katie Kilbane on +353 86 1283368 or email network@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Michael Marvin

JOB-13621

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