Medical Devices JobsSenior Quality Engineer (Validations)

  • GY51381
  • Temporary/Contract
  • Galway

Collins McNicholas

A global healthcare solutions company committed to improving the lives of people are seeking a Senior Quality Engineer (Validations) to join their business on a contract basis for 18 months.

Key Duties

  • You will lead the validation requirements for a product transfer to the Galway site providing input to process development and process validation.
  • You will work as part of a cross-functional team, providing expert Quality Engineering technical direction and 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/material 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 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.
  • Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.

 What you need to have

  • My client is looking for a person qualified to 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.
  • 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 part 820, MDR and ISO 13485 requirements is necessary.
  • Knowledge of statistical requirements or software validation requirements an advantage.
  • You are a good communicator and fluent in English, both in writing and speaking.

Please get in touch to find out more information and have a confidential discussion

elaine.dolan@collinsmcnicholas.ie

091 706 718

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