Job Details
|
|
|
| Quality Engineer II | | |
| Location: | | Europe (Non UK) | | |
Description
Our client, a large multinational company based in Cork, now seeks an experienced Quality Engineer.
Job Purpose:
To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
Key Responsibilities:
· Supervision of Quality Technicians and QC Inspectors.
· Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
· Provide effective and responsive QA support to Operations to meet their area’s 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’s)
· Drive and implement plant wide quality system improvements.
· Ensure Regulatory compliance in area of responsibility to cGMP’s 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)
· Approval of change requests for product, process and quality system changes.
· 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.
Education/Experience/Skills
· Ideally will possess Bachelor of Science Degree in Engineering/Technology.
· 3/4 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 necessary. · Excellent interpersonal and communication skills.
CCP Can Offer You
CV advice | interview coaching | tips & advice | CV advice | salary & benefits advice | career counseling | Career Direction - (full range of psychometric tools available)/Psychometric Testing Services/Occupational Personality Assessments (SHL Partner)
For further information please contact Joe Dervan at CCP Recruitment on 091 730022 or email | | |
Reference
IJ-JD/41720/IJP | | |
|
|
|
|
|
|
|
|
|
|
|
|
Jobseekers who looked at this job also looked at the following
|
|
|
|
|
|
|