Our client a major multinational here in Galway have an exciting opportunity for a Senior Supplier Quality Engineer.
The Senior Supplier Quality Engineer works with a Supplier Quality team who 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. They will liaise with our extensive network of suppliers to execute on quality improvements, cost savings, while managing and implementing Supplier driven changes. Part of a larger team within supplier quality department, this role would support post-market quality for components supplied to Galway.
- Ensures that suppliers deliver quality parts, materials, and services.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Builds a collaborative relationship with suppliers to quickly address any non-conformances.
- Drive appropriate root cause investigations with the supplier. Ensure corrective actions are implemented and monitor for desired results.
- Drive supplier improvement/corrective action through the following activities:
- Work with the supply base to drive corrective/preventative action based on feedback from incoming inspection supplier internal quality metrics and customer complaints.
- Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.
- Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).
- Provide technical assistance to suppliers/other resources performing qualification/validation testing.
- Ensure the resolution of all issues raised during testing/qualification.
- Collaborates with the operating platform to address issues and gain alignment when required.
- Represent the Supplier Quality group in operating meetings providing status updates on supplier base.
- Support supplier visits or audits as required.
- Support external regulatory and internal audits as required.
- You will work with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
- Work with the Enterprise Supplier group supporting creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for improvements.
- Define Receiving Inspection requirements as required and associated test method validation where required for internal Test Methods.
- Qualified to Level 8 in Science, Engineering, or relevant discipline.
- 4+ years Engineering and/or Quality experience in the medical industry or related field.
- You are a dynamic team player and can work effectively and proactively on cross functional teams.
- Excellent problem-solving skills are desirable.
- You are a good communicator and fluent in English, both verbal and written.
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 and leading teams.
- Experience with Process Validations and/or Test Method Validations (For example: IQ, OQ, PQ, and/or TMV)
- ISO 13485 Lead Auditor Certification.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717