Job Details
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| Quality Engineer | | |
| Location: | | Europe (Non UK) | | |
Description
Key Responsibilities:
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 and Skills
Minimum qualification: BSC/BEng degree.
Minimum of 2/3 years experience in a QA role
Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
Strong project management skills.
Good level of technical and analytical expertise to assist in problem solving.
Good knowledge of statistics would also be an advantage.
The recruiter is interested in your answers to the following question(s). Please place your answers in the email you send when applying for the job.
Question 1:
'Do you have a Minimum qualification of BSC/BEng degree?Do you have experience with process improvements, validation, customer complaints'
Question 2:
Do you have experience with process improvements, validation, customer complaints?
Question 3:
Do you have a Minimum of 2/3 years experience in a QA role? | | |
Reference
IJ-MK/33780/IJP | | |
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