|Job Ref:||204709496||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||City:||Cork||Address:||Salary:||£40 - £67/hour||Post Date:||29/09/2016 04:08|
Preetha Sampath is currently recruiting for a Supplier Quality Engineer to work within a manufacturing environment for a medical device company that manufacture a prestigious range of neuro and orthopaedic products. The Supplier Quality Engineer will be working at the site in Cork, Ireland on a 12 month contract basis. This client is offering a competitive salary and an opportunity to be involved in pioneering projects as well as access to state of the art facilities.|
This position is fully dedicated to the transformation/restructuring project and the ideal candidate will be responsible for the following:
•Drive new or revised special process validations as needed with specified suppliers
•Support evaluating vendor risk during outsourcing activities.
•Provide overall quality assurance leadership in the management of contract manufacturing sites
•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.
•Handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
•Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
As a Supplier Quality Engineer, you will have the following Qualifications, Skills and Experience:
•A minimum of a Bachelor's degree/Equivalent is required, preferably in an Engineering, Life Science, or related discipline.
•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.
•Experience or knowledge with machining manufacturing processes and injection molding an asset.
•Six Sigma, Lean, or ASQ Certification and training an asset.
•This position will require up to 25% travel with occasional international
CK Engineers is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG37192 in all correspondence