Principal Supplier Quality Engineer
Job ID: JOB-13204
Principal Supplier Quality Engineer (Hybrid)
Our Galway based Client who is a global leader in Medical Devices are seeking a Principal Supplier Quality Engineer to join their team on a permanent basis. 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 nonconformances.
- 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.–
Key Skills & Experience
- Qualified to Level 8 in Science, Engineering, or relevant discipline
- 7+ years Engineering and/or Quality experience in the medical industry or related field, or Level 9 degree with 5+ years’ experience.
- Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management.
- Experience with knowledge in Lean Principles.
- Experience with Agile, SAP & Microsoft Project an advantage.
- 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 further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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