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Quality & Validation Engineer II

ID
14160
Location
Westmeath
Role Type
Permanent
Contact
Mark Wilson
Email
talent@hero.ie
Phone
+353 86 0449473
LinkedIn
click here
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Position: Quality & Validation Engineer
Location: WestMeath
Onsite

Our Medical Device Client, a leader in the medical technology industry, is undergoing a significant transformation by separating its Patient Monitoring and Respiratory Interventions businesses. This move is aimed at advancing future growth and innovation, allowing for the reallocation of investments and resources.

 The intended separation creates a bold opportunity for our client’s team to unleash potential, move with speed and agility, and leverage increased investments to fuel meaningful innovation in patient care.

Key Responsibilities:

  • Provide QE 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.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • 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 & Performance Qualification activities.
  • Designs or specifies inspection and testing mechanisms; 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.
  • 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.
  • Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance actives. 

Key Skills & Experience:

  • Level 8 or higher qualification in Engineering/Science discipline.
  • Minimum of 3 years of relevant experience in a highly regulated environment.
  • Broad knowledge of manufacturing processes and quality systems.
  • Ideally experience with DFA (Design for Automation), GAMP5, Lean Sigma, Minitab.

For further information on this role in Athlone, Westmeath, commutable from Roscommon, Longford and Meath, please contact Mark Wilson on 0860449473 or email talent@hero.ieCheck out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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 standard 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 your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

 

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