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Senior Quality Engineer - Process Validation

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 19125

Our client a Major Multinational here in Galway we are seeking applications from a suitably qualified and experienced Senior Quality Engineer – Process Validation.


Responsibilities:

  • Work on New Product Development as part of a cross-functional team.
  • Provide Quality Engineering technical direction/input to process development. 
  • Provide expert QE technical direction/input to qualification and validation activities in conjunction with Design, Engineering, and extended QA teams.
  • Manage other process validation engineers as required. 
  • Author and support (input and critical review) of qualification/validation protocols/reports. 
  • 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 the 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. 
  • Support the introduction/implementation of process/materials changes to the manufacturing operation.
  • You will assess the impact on process validation for these changes.
  • Provide ongoing communication, information transfer, and record keeping in support of business and core-team objectives and metrics.

Requirements:

  • We are looking for a person qualified to a Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science) and desirably with a minimum of 5 years relevant experience. 
  • Experience working in the medical device or other regulated industry.
  • Experience of process validation activities in medical device or other regulated industry.
  • Be focused on patient and customer, set high standards and instill operational excellence.
  • Dynamic team player and can work effectively and proactively on cross-functional teams. 
  • Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability, Thinks Critically and Makes Sound Decisions. 
  • Knowledge of regulatory requirements and guidelines is an advantage.
  • Knowledge of statistical requirements and software validation requirements is an advantage. 
  • Good communicator and fluent in English, both in writing and speaking. 
  • Good organizational, presentation, and project management skills are desirable.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717