Senior Quality Engineer
- Wilton Park House, Wilton Pl, Dublin 2, Ireland, County Dublin (IRL)
- Negotiable
- 26 Weeks
- Start date: 31 May 22
- Ref: 5082203
- audit
- iso 13485
- compliance
- fda
- leadership
Job description
Posted 01 June 2022
Senior Quality Engineer - If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Meaghan at (086) 066 7944 or send your CV to mkenny@berkley-group.com
The Job:
Medical Device Company n is recruiting for a Senior Source Quality Engineer.
Responsibilities:
- Provide overall quality assurance leadership in the management of suppliers engaged in the production of Johnson and Johnson 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 transfer programs.
- Supplier Process validation and approval in line with internal and regulatory requirements.
- 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).
- 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.
- Work with the Sourcing teams to ensure the supply base is optimized to reflect the most efficient processes
Have you?
- A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
- A minimum of 5 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.
- Six Sigma, Lean, or Lead auditor Certification and trainings an asset.
- This position may require some EU based travel
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Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
