Principal Supplier Quality Engineer

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Principal Supplier Quality Engineer

Apply Now

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. 

Key Responsibilities

  • 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 talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13204

Apply Now

Principal Supplier Quality Engineer

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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