Job Detail

Location Galway
Salary Negotiable
Role Type Contractor
Contact Clara Burke

Senior Quality & Validation Engineer

Senior Quality & Validation Engineer
A leading medical device company is looking to hire a Senior Quality & Process Validation Engineer on a 6 month contract, working from home.

At the Process Validation Department, the focus is on providing process validation support during the full lifecycle of the product. From initial development of new products to ongoing support when products have been commercialized, ensuring that the performance and safety of the devices we support is maintained through the product lifecycle.

  • As part of a cross-functional team, provide Quality Engineering technical direction/input to the product development process and the execution of technology transfer plans.
  • Provide expert QE technical direction/input to qualification and validation activities in conjunction with Engineering and extended QA teams.
  • Author and support (input and critical review) of qualification/validation protocols/reports.
  • Support the introduction/implementation of process/materials changes to the manufacturing operation. You will assess the impact on process validation for these changes.
  • Function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback and quality leadership.
  • Understand product construction, features and uses at a highly competent level to contribute to decision making process on product acceptance standards within their scope of responsibility.
  • Lead or support root cause investigations; drive problem solving efforts for quality issues.
  • Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.

Key Skills & Experience

  • Qualified to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
  • A minimum of 5 years relevant experience.
  • You are a dynamic team player, can work effectively and proactively on cross-functional teams.
  • Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
  • Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is necessary.
  • Knowledge of combination products, statistical requirements or software validation requirements an advantage.
  • You are a good communicator and fluent in English, both in writing and speaking.

For further information on Senior Quality & Validation Engineer role in Galway please contact Clara Burke on 086 8168273 /

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Senior Quality & Validation Engineer

Clara Burke

Role Type Contractor
Contact Clara Burke
mobile +353 86 816 82 73
linkedIn profile click here

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