A Senior Supplier Quality Engineer is required by CareerWise Recruitment for our Cork based medical device manufacturing client. This is an initial 12 month contract role. Please contact Diarmuid Buckley for more information.
Role of this position
- Provide overall quality assurance leadership in the management of suppliers engaged in the production of products.
- Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
- Supplier Development including Robust process implementation and Inspection Readiness.
- Change control management and qualification of supplier process changes and supplier transfers programs.
- Supplier Process validation and approval in line with internal and Regulatory requirements.
- Project management - planning, scheduling, tracking and execution of project activities as part of supplier and part qualification.
- Promote continuous improvement and Process Excellence activities within the Global Supply Chain
- Resolve problems & eliminate constraints to ensure project and supply targets are met.
- L8 Bachelor's degree preferably in an Engineering, Life Science, or related discipline.
- 5+ years experience in a highly regulated industry is required.
- Experience in the Medical Device industry and/or Pharmaceutical industry preferred
- FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.
- Six Sigma, Lean, or Lead auditor Certification and trainings an asset.
Please call Diarmuid Buckley today for further information on 021 -4355432 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)