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Senior Supplier Quality Engineer

Job Title: Senior Supplier Quality Engineer
Contract Type: Contract
Location: Cork
Industry:
REF: 88323
Job Published: 9 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Senior Supplier Quality Engineer
Our client a leading pharmaceutical company based Cork requires a Senior Supplier Quality Engineer for a contract role.

Responsibilities:
  • Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of pharmaceutical products.
  • Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
  • 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).
  • Report on contract manufacturer performance metrics.
  • Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
  • Ensure External Manufacturers continue to meet Quality requirements with regard to Supplier Change Request process of the company
  • Promote continuous improvement and Process Excellence activities within the Global Supply Chain
  • Resolve problems & eliminate constraints to ensure project and supply targets are met.


Education, Experience and Skills:
  • 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.
  • Auditing background is an asset.
  • Experience in root cause analysis is required.
  • Six Sigma, Lean, or ASQ Certification and trainings an asset.
  • This position will require travel
  • Non Technical Skills and Additional Details

For further information on this Quality Job in Cork please contact Bimi Felix on 091 730022/ bimi@hero.ie
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