Our client a medical device company is looking to hire a supplier Quality Engineer for their site on a contractual basis for 12 months.
At our Supplier Quality Department we partner with our suppliers to deliver the highest quality and most reliable products to our customers.
The Supplier Quality role works with external suppliers and in a cross-functional team on a daily basis to resolve supplier related issues, drive continuous improvement while driving key quality metrics across the Galway Campus. Part of a larger team within supplier quality department, this role would support new product development and post market quality for components supplied to Galway.
- Work closely with project team to drive continuous improvement and robust corrective actions through problem solving techniques at supplier to prevent recurrence of issues, and ultimately deliver high-quality products to customers
- Communicate with management and project teams on a regular basis on supplier performance
- Develop strong partnerships with cross functional groups and provide quality leadership within these groups
- Provide technical direction/input into the development of component documentation and execution of project plans
- Support in the review of supplier introduction and changes, coordinating activities with suppliers and with internal cross-functional support teams to develop and implement appropriate strategies to qualify and support
- Ensure appropriate controls are in place at supplier, based on risk associated with product or service
- Provide expert QE technical direction input to component qualification strategies and documentation in conjunction with project teams to ensure high standards are in place
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
Key Skills & Experience
- We are looking for a person qualified to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science or technical field)
- Minimum of 2 years relevant experience, or less with an advanced degree
- You are a dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills
Nice to Have
- Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is an advantage.
- Previous experience in Supplier Quality.
- Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV).
- ISO 13485 Lead Auditor Certification
For further information on this Supplier Quality Engineer role please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
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