Quality Engineer II Galway
This Quality Engineer II job is a permanent one. My client, a leading medical device company, are looking for an experienced, articulate and driven Quality Engineer II to join their Galway site.
- 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).
- 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, product and test method 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. Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Education, Experience and Skills;
- Bachelor of Science Degree in Engineering/Technology.
- 2/3 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.
- Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
If you're free for a quick chat to find out more about this Quality Engineer II job in Galway or any other Quality Engineering jobs then please call me on my mobile 0868395533.
If you can't talk during the day, please text me and I can ring you at a time that suits.
I look forward to hearing from you, Cliona O Malley - Recruitment Consultant Life Sciences Division with HERO Recruitment (firstname.lastname@example.org)
Please Note: HERO Recruitment will not forward your details to any company without your prior approval