Job Details
|
|
|
| Senior Quality Engineer | | |
| Location: | | Europe (Non UK) | | |
Description
Key Responsibilities:
Supervision of Quality Technicians and Quality Engineers
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: 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.
Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities.
Education, Experience and Skills
Minimum of Bachelor of Science Degree in Engineering/Technology.
4/5 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
Experience in the medical device industry is 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 of Bachelor of Science Degree in Engineering/Technology?'
Question 2:
Do you have 4/5 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated)?
Question 3:
Do you have experience driving and implementing 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 | | |
Reference
IJ-MK/33760/IJP | | |
|
|
|
|
|
|
|
|
|
|
|
|
Jobseekers who looked at this job also looked at the following
|
|
|
|
|
|
|