Senior Quality Engineer – Process Validation
What you need to know
You will work as a Senior Quality Engineer in Process Validation for our client, a highly successful and established Medical Device company in Co. Galway.
In the Process Validation Department, our client focuses 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 they ensure that the performance and safety of the devices they support is maintained through the product lifecycle.
This is a contract job.
Your new job
Key duties & responsibilities:
- As part of a cross-functional team, provide Quality Engineering technical direction/input to the product development process.
- 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.
What are we looking for?
- 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.
- Dynamic team player, that 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.
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