Quality Engineer

Ref. no.: 59348

Tags: Quality Engineer

Location(s): Cork

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 3 - 4 Years

Employment type: Permanent Full-time

Minimum qualification: See Description

Contact person: Richmond Cork

Contact e-mail: corkjobs@richmond.ie

Job description: At RICHMOND RECRUITMENT our client is looking to recruit a Quality Engineer.

Provide effective and responsive QA support to Operations to meet their area objectives of quality, cost and output. Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA Drive and implement plant wide quality system improvements.

Ensure Regulatory compliance in area of responsibility to cGMP of all medical device regulatory agencies (e.g. FDA and TUV) Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles). Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)

Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
Validation: Define process and product validation requirements, preparation and approval of Master Validation
Plans, protocols and reports approval. Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).

MRB: Review of MRB trends and identification of appropriate corrective actions when required. Perform internal quality audits. Support the implementation of Lean Manufacturing across the site. Transfer and implement product and processes from development or from another manufacturing facility.

For further information forward CV to the email address provided and/or phone Eddie on 021 450 0355 for a confidential discussion