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Supplier Quality Engineer

  • Job reference: 930708
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 06/04/2020

Orion Group Life Sciences have an exciting opportunity for a Supplier Quality Engineer for our Multinational Medical Device client based in the Cork on an initial 6 month contract.


Job Purpose
The Supplier Quality Engineer will provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. They will be required to provide overall quality assurance leadership in the management of suppliers engaged in the production of products.


Main Responsibilities of the role
* Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO).
* Understand supplier performance metrics and what they mean to the business
* Promote continuous improvement and Process Excellence activities within the Global Supply Chain
* Change control management and qualification of supplier process changes and supplier transfers programs.
* Resolve problems & eliminate constraints to ensure project and supply targets are met.
* Work with the Sourcing teams to ensure the supply base is optimized to reflect the most efficient processes;
o Identify requirement to transfer identified products to alternate supplier or obsolete product
o Execute product equivalency assessments
o Perform QIR and system updates
o Create spec and drawing approvals
o Lead PVE with responsibility for associated documentation
o Escalate timeline risk with mitigation recommendations
o Collaboration with internal cross-functional team members and suppliers on timeline execution for SQE responsibilities
o Liaise with internal stakeholders to ensure any supplier-based decisions are understood and accepted at site level


Desired Experience and Background of the successful candidate

  • A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
    * A minimum of 6 years of experience in a highly regulated industry is required.
    * Experience in the Medical Device industry and/or Pharmaceutical industry is required.
    * FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.
    * Experience in root cause analysis is required.
    * Six Sigma, Lean, or ASQ Certification and trainings an asset.
    * This position may require some EU based travel

    #medicaldevices #medical #device #13485 #multinational #Quality #implant #Engineering

For more information on this role, call Dan Ryan on +353868140295 or email Daniel.ryan@orioneng.com for a completely confidential chat about this role and other opportunities


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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