- Reference: CJ43635
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
- 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.
- 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. FDAISO 9000 necessary.
- Excellent interpersonal and communication skills.
- Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
- Experience/training in problem solving and process improvement methodologies (Engineering Essentials TM).
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!