Job ID: JOB-11736
Senior Quality Engineer – Process Validation

A leading medical device manufacturer in Galway is recruiting for a Senior Quality Engineer in Process Validation to join their team on a permanent basis.

Purpose

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, to ensure that the performance and safety of the devices we support is maintained through the product lifecycle.

Key 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.
• 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 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 on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.

Key Skills & Experience

• We are looking for a person qualified to Minimum of a Bachelors 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, 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.
• You are a good communicator and fluent in English, both in writing and speaking.

For more information on this role in Galway please contact Clara Burke on 086816823 or science@hero.ie

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Clara Burke

JOB-11736